Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education: A Randomized Controlled Trial Focusing on HbA1c and Glucose Variability in Patients With Type 2 Diabetes (The BCC Study)
Phase: NA
Conditions: Type2 Diabetes, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
Sponsor: Steno Diabetes Center Copenhagen

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
 
 
 
CLINICAL STUDY PROTOCOL 
 
Effects of basic carbohydrate counting versus standard outpatient 
nutritional education: A randomized controlled trial focusing on 
HbA1c and glucose variability in patients with type 2 diabetes 
(The BCC Study) 
 
 
 
 
Trial site  
Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark 
 
 
 
Version 8.0 Final 08.08.19 
 
 
 
 
Principal investigator  
Bettina Ewers  
PhD student and Head of Nutrition, MSc 
Steno Diabetes Center Copenhagen 
University of Copenhagen 
Niels Steensens Vej 2, DK-2820 Gentofte 
Denmark 

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List and contact information on principle investigator and co-investigators 
 
 
Principal investigator:  
 
PhD student and Head of Nutrition, Bettina Ewers MSc., Steno Diabetes Center Copenhagen, 
University of Copenhagen, Niels Steensens Vej 2, DK-2820 Gentofte, Denmark. E-mail: 
bettina.ewers@regionh.dk Phone: +45 30912997. 
 
Co-investigators: 
Professor, Head of Clinic Tina Vilsbøll, MD DMSc, Steno Diabetes Center Copenhagen, Niels 
Steensens Vej 2, 2820 Gentofte, Denmark. E-mail: tina.vilsboell.lauritsen@regionh.dk Phone: +45 
38672461. 
 
Professor, Chief Physician Jens Meldgaard Bruun, MD PhD, Department of Nutrition, Exercise and 
Sports, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark. E-mail: 
jens.bruun@clin.au.dk Phone: +45 50945547. 
 
Professor, Chief Physician Filip K Knop MD PhD, Clinical Metabolic Physiology, Steno Diabetes 
Center Copenhagen at Gentofte Hospital, Kildegårdsvej 28, DK-2900 Hellerup, Denmark. E-mail: 
filip.krag.knop.01@regionh.dk Phone: +45 26830161.  
 
 
Associate Professor, Chief Physician, Research Leader Henrik Vestergaard MD DMSc, Steno 
Diabetes Center Copenhagen and The Novo Nordisk Foundation Center for Basic Metabolic 
Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of 
Copenhagen, Blegdamsvej 3B, DK-2200 Copenhagen, Denmark. E-mail: 
henrik.vestergaard@regionh.dk Phone: +45 21781034. Clinical responsible physician. 
 
Chief Physician Henrik Ullits Andersen, MD DMSc, Steno Diabetes Center Copenhagen, Niels 
Steensens Vej 2, DK-2820 Gentofte, Denmark. E-mail: henrik.ullits.andersen@regionh.dk  Phone: 
+45 30912850. 
Professor Helle Terkildsen Maindal MPH PhD, Section of Health Promotion and Health Services 
Research, Department of Public Health, Aarhus University, Bartholins Allé 2, building 1260, DK-
8000 Aarhus, Denmark. Email: htm@ph.au.dk Phone: +45 25462320.  
 
Professor, Head of Section Lars Ove Dragsted MSc PhD, Preventive and Clinical Nutrition, 
Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 26, 1958 
Frederiksberg C, Denmark. E-mail: ldra@nexs.ku.dk Phone; +45 35332694. 
 

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Signatures and agreement with protocol 
We, the undersigned, acknowledge that we have read this protocol. We agree to conduct this study in 
accordance with the study protocol, the current version of the Declaration of Helsinki, the 
International Conference on Harmonization E6 Good Clinical Practice to that extent that this is 
relevant and possible for a non-medical intervention. In addition, all national laws and regulations of 
the local ethical committee regarding human research will be strictly enforced.  
 
 
 
Principal / Coordinating Investigator 
Date 
Bettina Ewers, MSc  
Steno Diabetes Center Copenhagen 
 
 
Investigator  
 
Date 
Tina Vilsbøll, MD DMSc 
Steno Diabetes Center Copenhagen 
 
 
Investigator  
 
Date 
Filip Krag Knop, MD PhD 
Steno Diabetes Center at Gentofte Hospital 
 
 
Investigator  
 
Date 
Jens Meldgaard Bruun, MD PhD 
University of Copenhagen 
 
 
Investigator, Clinical responsible physician  
Date 
Henrik Vestergaard, MD DMSc 
University of Copenhagen 
 
 

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3 
Table of contents 
 
1 
List and contact information on principle investigator and co-investigators ................. 2 
2 
Signatures and agreement with protocol ............................................................. 3 
3 
Table of contents ........................................................................................... 4 
4 
List of tables and figures ................................................................................. 7 
5 
Abbreviations and definition of terms ................................................................. 8 
6 
Introduction ................................................................................................. 9 
6.1 
Background .......................................................................................... 9 
7 
Main hypothesis ............................................................................................ 11 
7.1 
Sub-hypotheses .................................................................................... 11 
8 
Objectives................................................................................................... 11 
8.1 
Primary objective ................................................................................. 11 
8.2 
Secondary objectives ............................................................................. 11 
9 
Investigational study design ............................................................................ 12 
9.1 
Study endpoints .................................................................................... 12 
9.1.1 
Primary outcome ................................................................................ 12 
9.1.2 
Secondary outcomes ............................................................................ 12 
9.1.3 
Dietary adherence markers .................................................................... 12 
9.2 
Study design ........................................................................................ 13 
9.3 
Interventions ....................................................................................... 13 
9.3.1 
Basic carbohydrate counting intervention .................................................. 13 
9.3.2 
Control group .................................................................................... 14 
9.3.3 
General instructions ............................................................................ 14 
9.3.4 
Dietary compliance ............................................................................. 15 
9.4 
Recruitment of participants ..................................................................... 15 
9.5 
Study participants ................................................................................. 17 
9.5.1 
Inclusion criteria ................................................................................ 17 
9.5.2 
Exclusion criteria ................................................................................ 17 
9.5.3 
Criteria for withdrawal ......................................................................... 17 
9.6 
Participant information .......................................................................... 18 
9.7 
Screening procedure and informed consent................................................. 18 
9.8 
Randomisation...................................................................................... 19 
9.9 
Patient outcome ................................................................................... 19 
9.10 
Study feasibility .................................................................................... 19 
10 Examinations ............................................................................................... 21 
10.1 
Clinical examination .............................................................................. 22 
10.2 
Blood samples ...................................................................................... 22 
10.3 
Urine samples ...................................................................................... 22 
10.4 
Continuous Glucose Monitoring ................................................................ 23 

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10.5 
Body fat distribution .............................................................................. 23 
10.6 
Dietary assessment ................................................................................ 23 
10.7 
Questionnaires ..................................................................................... 24 
10.8 
Electronic medical record data ................................................................. 24 
10.9 
Other baseline demographics ................................................................... 24 
10.10 
Physical activity level ............................................................................ 25 
11 Study visits .................................................................................................. 26 
11.1 
Study information ................................................................................. 27 
11.2 
Screening ............................................................................................ 27 
11.3 
V1: Baseline (week -4 to -1) .................................................................... 27 
11.4 
V2: Start of intervention, day 1 (week 0) .................................................... 27 
11.5 
V3: intervention, day 2 (week 12) ............................................................ 28 
11.6 
V4: intervention, day 3 (week 20) ............................................................ 28 
11.7 
V5: After 24 weeks of intervention ........................................................... 28 
11.8 
V6: Follow-up at 48 weeks (24 weeks after intervention completion) ................ 28 
12 Laboratory analyses ...................................................................................... 29 
12.1 
Laboratory .......................................................................................... 29 
12.2 
Sample handling ................................................................................... 29 
12.3 
Storage of samples ................................................................................ 30 
12.4 
Samples for a research biobank and a biobank for future research.................... 30 
13 Statistical methods and determination of sample size ............................................ 32 
13.1 
Calculations ......................................................................................... 32 
13.2 
Statistical methods ................................................................................ 32 
13.3 
Determination of sample size ................................................................... 32 
14 Data management ......................................................................................... 33 
14.1 
Data handling and quality assurance .......................................................... 33 
14.2 
Source data identification and verification .................................................. 33 
14.3 
Data reporting and protection .................................................................. 33 
14.4 
Study files ........................................................................................... 33 
15 Ethics and regulations .................................................................................... 34 
15.1 
Independent ethics committee and regulatory authority ................................ 34 
15.2 
Ethical conduct of the study .................................................................... 34 
15.3 
Risks related to participation ................................................................... 34 
15.4 
Insurance of the patients ........................................................................ 35 
15.5 
Protocol changes................................................................................... 35 
15.6 
Protocol deviations ................................................................................ 36 
16 Organisation ................................................................................................ 37 
16.1 
Study tasks .......................................................................................... 37 
17 Publication .................................................................................................. 38 
17.1 
Authorship .......................................................................................... 38 

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18 Study time-frame .......................................................................................... 39 
19 Initiative and financing .................................................................................. 40 
20 References .................................................................................................. 41 
21 List of appendices ......................................................................................... 44 
 

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4 
List of tables and figures 
 
List of tables 
 
Table 1 
Schematic overview of study visits 
Table 2 
Table 3 
Table 4 
Table 5 
Maximum volume of blood collected 
Maximum volume of urine collected 
Analysis of biochemical samples  
Sample size calculations 
 
 
List of figures 
Figure 1 
Figure 2 
Study design  
Visit flow 
 
 

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5 
Abbreviations and definition of terms 
 
App 
Application 
BCC 
Basic carbohydrate counting 
BMI 
Body Mass Index 
CGM 
Continuous Glucose Monitoring 
D 
Days 
DXA 
Dual-energy-X-ray absorptiometry 
FFA 
Fatty Free Acids 
HbA1c 
Glycosylated haemoglobin A1c 
HDL-C 
High-density-lipoprotein cholesterol 
ICH-GCP 
International conference on harmonization – Good Clinical Practice 
Intervention 
Group education in BCC. This period runs from week 0 to week 24 
ITT 
Intention-to-treat 
LDL-C 
Low-density-lipoprotein cholesterol 
MAGE 
Mean amplitude of glycaemic excursions 
Mg 
Milligram 
Min 
Minutes 
Ml 
Millilitre 
N 
Sample size 
PI 
Principal Investigator 
PP 
Per protocol 
RA 
Regulatory authority 
SD 
Standard deviation 
SOP 
Standard operational procedure 
TC 
Total cholesterol 
TG 
Triglycerides 
V 
Visit 
Wk 
Week 
 
 
 

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6 
Introduction 
6.1 Background 
Weight management is an important aspect of type 2 diabetes (T2D) and even a modest weight loss 
has been shown to improve glycaemic control and reduce the need for glucose-lowering medication in 
patients with T2D (1, 2). Accordingly, the national and international clinical guidelines for the 
management of T2D recommend calorie restriction as the primary dietetic approach for body weight 
control to improve metabolic control. However, no clear recommendations for an ideal dietary 
macronutrient composition exists (3-5). In contrast, European and American guidelines recommend 
carbohydrate counting or similar methods as another important strategy for achieving glycaemic 
control in patients with T2D (6-9). 
 
Carbohydrate is the main energy contributing nutrient in our diet with the highest impact on plasma 
glucose levels. In contrast, protein, fat, and alcohol have limited effect on postprandial plasma glucose 
levels, but obviously have a significant impact on the total energy balance (7, 9). The total amount of 
carbohydrates consumed in a meal is a significant predictor for the postprandial glucose response, 
however, both the quantity and quality (e.g. dietary fibre, added sugar and glycaemic index) of 
carbohydrates influence plasma glucose levels (7, 9). Thus, monitoring the dietary intake of 
carbohydrates may be important to control postprandial glucose fluctuations, which may lead to 
clinical benefits such as a reduction in glucose variability and the number of hyperglycaemic and 
hypoglycaemic episodes besides improvements of glycated haemoglobin A1c (HbA1c) and potentially 
to a reduction in diabetes-related complications. These assumptions form the basis for the concept of 
carbohydrate counting as a method to achieve a better metabolic control in patients with T2D. 
 
Two levels of carbohydrate counting have been defined internationally with different learning 
objectives and increasing complexity; a basic and an advanced level (10-12). Basic carbohydrate 
counting (BCC) is a method for patients with diabetes aiming at increasing their awareness of dietary 
intake of carbohydrates. Focus of BCC is for the patients to obtain knowledge of the importance of 
consistency in the timing and the amount of carbohydrates consumed, which foods are rich in 
carbohydrates, skills in reading food labels, and accurate carbohydrate estimation. All steps in BCC 
aim at an overall improvement in the control of plasma glucose. Advanced carbohydrate counting 
(ACC) is targeted the patient who ideally masters BCC and is treated with multiple daily insulin 
injections (MDI) and is prepared to learn how to match fast acting insulin dosages according to 
carbohydrate intake using carbohydrate-insulin ratios and sensitivity factor. In other words, the ACC 
concept does not apply to all patients with T2D because of the complex treatment regimens (e.g. oral 
antidiabetic agents or other types of insulin than fast-acting meal insulins), potential patient barriers 
(e.g. difficulties in implementing the method in a real-life context), lack of motivation to learn the 
method (e.g. too time consuming to match insulin according to the carbohydrate content in each meal, 
or do pre- and postprandial plasma glucose monitoring), and low levels of education, literacy or 
numeracy skills. Other barriers include lack of appropriate learning environments to promote 
behavioural change and availability of trained dietitians to facilitate the learning process (13).  
 
In the clinical guidelines and human studies, the term “carbohydrate counting” is often used 
synonymously with ACC. Systematic reviews and meta-analysis of randomized controlled trials 
(RCTs) have shown that ACC can improve HbA1c in patients with type 1 diabetes (14-16). Only two 
RCTs (17, 18) have investigated the effect of ACC in patients with T2D on intensive insulin therapy 
and found limited HbA1c effects, while only one recent RCT from the US has investigated the effect 
of BCC in patients with T2D and found a modest effect on HbA1c (19), which need to be confirmed. 
  

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Accurate portion-size estimation is an important skill in BCC to obtain consistency in the daily 
carbohydrate intake and is also an important component of weight management. Recent studies 
suggest that lower literacy and numeracy skills are associated with poorer portion size estimation 
skills and understanding of food labels, increased body mass index (BMI), and poorer diabetes-related 
self-management abilities (20-24). Studies have found that patients with diabetes frequently assess 
their intake of carbohydrates inaccurately and this has been associated with a poorer HbA1c (25-27). 
Particularly mixed meals, high-calorie dense foods, and larger portion sizes resulted in inaccurate 
carbohydrate estimation. Thus, dietary awareness and insight concerning carbohydrate-rich foods, 
hands-on experience in accurate carbohydrate estimation of individual foods and practising 
mathematical literacy skills seems to be important for obtaining better glucose control. Increased 
dietary awareness of the carbohydrates being consumed may also lead to a reduced carbohydrate 
consumption and thus a reduced energy intake. This has been shown to be an efficient dietary 
approach in patients with T2D for body weight loss and improvement in HbA1c (28, 29).  
 
The ideal amount of carbohydrates in the diet in the management of T2D remains unclear. A 
systematic review and meta-analysis of dietary carbohydrate restriction in patients with T2D (30) only 
found short term improvements (<1 year) of HbA1c, body weight and LDL cholesterol from 
consuming low-carbohydrate diets (<45 E%) compared to high-carbohydrate diets containing 45-60 % 
of the total energy from carbohydrates in accordance with the dietary recommendations (8, 31). The 
short-term effects of low-carbohydrate diets may be due to higher drop-out rates observed suggesting 
a decline in dietary adherence of low-carbohydrate diets over time and indicating that the intake of 
carbohydrates should be based on an assessment of the current eating patterns and preferences. 
 
Evidence suggest that a hands-on, learning-by-doing approach (problem- and experience-based patient 
education) can support the development of food skills in general, and improve diet quality in 
particular (32). Adding group-based dietary approaches to individual lifestyle counselling has also 
been found to improve dietary habits (33). Similarly adding diabetes self-management approaches to 
the diabetes education lead to lower dropout rates, increased self-efficacy and improved HbA1c in 
patients with T2D (34). This may be due to the fact that diabetes self-management education supports 
achieving personal goals for behaviour change that in turn could lead to better clinical outcomes. 
 
The sparse scientific knowledge about the effect of BCC underlines the need for investigating and 
evaluating this in a practice-based group educational approach and examining the effect on improved 
metabolic control in patients with T2D.   
 
In a small pre-post design study of 29 participants with T2D conducted at Steno Diabetes Center 
Copenhagen (SDCC) we found that patients offered a structured group education program in BCC 
improved their carbohydrate counting skills (p<0.001) and reported increased knowledge concerning 
types and amounts of carbohydrates and how to prevent hyper- or hypoglycaemia. However, no 
significant changes in HbA1c (p=0.08) or body weight (p=0.616) where found after six months 
(unpublished data). Despite the limited clinical effects in this small study the initial results are 
interesting and call for additional research in a stronger randomized set-up and with power to 
investigate whether a group-based dietitian-delivered program in BCC has an independent effect on 
glycaemic control and body weight management in patients with T2D in up to 12 months to assess if 
dietary adherence to the BCC program is still high after one year.  
 

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7 
Main hypothesis 
Training and education in the BCC concept will improve glycaemic control either by reducing HbA1c 
or the average plasma glucose variability more than offering a standard nutrition education (control) 
as a stand-alone dietary treatment. The underlying mechanisms are that nutrition education in BCC 
will improve the patients’ knowledge and awareness of the ingested amount of carbohydrates, the 
accuracy of carbohydrate estimation together with focus on higher consistency (reduced variability) in 
the carbohydrate intake, all of which will reduce glucose variability and HbA1c.  
7.1 
Sub-hypotheses 
• 
Any investigated clinical impact of the BCC intervention compared to standard nutritional 
education alone may be mediated through improved skills in mathematical literacy, a higher 
accuracy in carbohydrate estimation or more consistency in the carbohydrate intake. Anticipating 
that participants with no improvements in carbohydrate portion estimation accuracy or in 
mathematical literacy, or with low adherence to the dietary recommendations for carbohydrate 
consistency at the end of the study may not benefit clinically from the BCC program 
• 
Diet-related quality of life may drop in the BCC group due to a more rigorous dietary regimen 
aiming at more regular meals eating a relatively fixed amount of carbohydrates at meals inducing 
a feeling of less freedom to eat as one wish 
• 
Greater perceived competencies and support for autonomy will lead to improved glycaemic 
control through improved diabetes self-management 
• 
Objective measurements of dietary adherence may improve clinical effects of BCC education in 
high dietary adherence participants 
 
8 
Objectives 
The overall objective is to compare the effect of a nutritional program in BCC as an add-on to the 
routine outpatient nutritional education on glycaemic control (HbA1c and plasma glucose variability) 
in adult patients with T2D after six months of intervention. 
8.1 Primary objective 
The primary objective is to evaluate the six months health benefits of nutritional education in the 
BCC concept compared to standard nutritional education on glycaemic control as assessed by HbA1c 
or MAGE (mean amplitude of glycaemic excursions).  
8.2 Secondary objectives 
The secondary objectives are to evaluate the health benefits at six months follow-up. Additional 
objectives are to examine the impact of nutrition education in BCC on other clinical relevant 
metabolic changes (body weight, body composition, blood pressure and lipid profile), changes in 
mathematical literacy and carbohydrate estimation accuracy as well as on psychosocial and 
behavioural factors. These include changes in diet-related quality of life, perceived competencies in 
diabetes and degree of autonomy-supportive dietitians in relation to health-related behavioural change 
and adherence to dietary self-care recommendations based on biomarkers of health outcomes at the 
end of the intervention period and after 6 months of follow-up.  
 
 
 
 

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9 
Investigational study design  
9.1 Study endpoints 
9.1.1 Primary outcome  
Reduction in HbA1c or MAGE from baseline to the end of the intervention (week 24) between and 
within each of the two study groups (BCC and control).  
 
9.1.2 Secondary outcomes 
Changes in HbA1c from baseline to 6-months follow-up (week 48) between and within the two study 
groups (BCC and control). 
 
Changes from baseline to the end of the intervention period (week 24) and at 6-month follow-up 
(week 48) between and within the two study groups (BCC and control) in:   
• 
Body weight  
• 
Blood pressure 
• 
Lipid profile: low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol 
(HDL-C), total cholesterol (TC), free fatty acids (FFA) and triglycerides (TG) 
• 
Waist and hip circumference 
• 
Mathematical literacy  
• 
Carbohydrate estimation accuracy  
• 
Self-reported diet-related quality of life, perceived competencies in diabetes, health-care climate 
and physical activity  
 
Changes from baseline to the end of the intervention (week 24) between and within study groups in:  
• 
Other parameters of plasma glucose variability including time in range (3.9-10.0 mmol/l), % time 
spent in hypoglycaemia (<3.9 mmol/l), % time spent in hyperglycaemia (e.g. >11.1 mmol/l) and 
standard deviation of mean plasma glucose 
• 
Body composition  
• 
Dietary intake (total energy, intake of carbohydrate, fat, protein, added sugar and dietary fibre) 
 
9.1.3 Dietary adherence markers 
• 
Urinary biomarkers (metabolomic profile in urine)  
• 
Dietary food records  
• 
Use of personal carbohydrate meal plan diary 
 
Assessment of study outcomes is described in detail in section 10. 
 

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9.2 Study design 
The study is designed as a randomized, controlled intervention trial with a parallel-group design (Fig. 
1). A total of 226 patients with T2D will be enrolled in the study. For each participant, the total study 
duration is 48 weeks, and includes up to nine visits at the study site in total. Each study visit is 
described in detail in section 11. 
 
Participants will be randomized to one of two arms:  
Group A: Standard medical and dietary care (control group) n=113 
Group B: BCC education delivered in addition to standard medical and dietary care n=113 
 
 
 
 
 
 
 
 
Figure 1 Study design 
 
9.3 Interventions 
9.3.1 Basic carbohydrate counting intervention 
Participants randomized to the BCC intervention group will receive standard dietary care targeted 
patients with T2D treated in a specialized outpatient diabetes clinic with a BCC program as an add-
on. The routine dietary care includes one initial individual dietary counselling (60 min) and two 
individual follow-up counselling sessions (2 x 30 min) by a trained dietitian. The BCC program is 
described below. 
 
Composition of the BCC program:  
• 
Two 180 min interactive group sessions 
• 
One 120 min interactive follow-up session  
 
The BCC program consists of two sessions of three hours with two weeks in between and a follow-up 
session of two hours after 10 weeks delivered by trained dietitians. The BCC program is a group-
based educational program based on several years of experience with this BCC concept at SDCC. The 
BCC program uses trained dietitians as educators following a planned curriculum which include 
experience-based leaning with problem-solving exercises, hands-on activities, short theoretical 
presentations, discussions of motivational aspects and coping strategies. The BCC program integrates 
peer modelling, skill development, goal setting, observational learning and social support into the 
program content and activities. The training includes identifying carbohydrates in food, reading 
carbohydrate tables, calculating the carbohydrate content from food labels, tables and applications 
(app) for smartphones and use of a personalized carbohydrate plan with guiding suggestions for daily 

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intake of carbohydrates at meals based on personal dietary recordings including plasma glucose 
measurements. An app from the Danish Diabetes Association (Diabetes og Kulhydrattælling®. The 
Danish Diabetes Association’s app, Pragma soft A/S, available in Google Play® and App Store® 
12/2014, Free) will be introduced to support estimation and calculation of carbohydrates. 
 
Participants will receive the usual dietary care during the same initial 20 weeks of the intervention as 
the BCC program (see Figure 2 for a detailed description of visit flow). After the 20 weeks, the 
participants are not allowed to receive further dietary education by a dietitian. Participants are 
encouraged to follow their dietary plan according to their intervention for another four weeks until 
week 24 followed by a 6-months follow-up period. During the intervention period and follow-up 
period participants are followed as usual in the diabetes clinic at SDCC or SDCC-Gentofte Hospital 
for a total of 48 weeks. 
 
The BCC courses will consist of both study participants and patients since the courses are a part of a 
non-standard nutrition education initiative running at SDCC as a supplement to standard care, funded 
by the Novo Nordisk Foundation. The courses are targeted patients with T2D treated at SDCC and 
SDCC-Gentofte Hospital and runs in the period 2018-2020. Close relatives are included in the courses 
if participants or patients need extra support to manage dietary changes based on an individual 
assessment by the principle study investigator. 
  
9.3.2 Control group 
Participants randomized to the control group will receive standard outpatient dietary care which 
includes one initial individual dietary counselling (60 min) and two individual follow-up counselling 
(2 x 30 min) by a trained dietitian based on the overall treatment goal of reducing HbA1c setting 
personal dietary goals for behavioural change according to individual patient preferences. Dietary 
guidance includes topics such as healthy dietary habits and weight loss approaches according to the 
national food-based dietary guidelines (“De 10 kostråd”), replacement of high calorie foods with low 
calorie foods or special attention to carbohydrate sources (e.g. glycaemic index and dietary fibre 
intake). Besides the three individual dietary counselling sessions, the participants are not allowed to 
receive further dietary education by a dietitian. Participants are encouraged to follow their dietary 
plan for another four weeks until week 24 followed by a 6-months follow-up period. During the 
intervention and follow-up period participants are followed as usual in the diabetes clinic at SDCC or 
SDCC-Gentofte Hospital for a total of 48 weeks. 
 
9.3.3 General instructions 
All study participants will be instructed to maintain their habitual lifestyle in all other aspects than 
their diet, e.g. keeping the same level of physical activity during the study period. Additionally, all 
study participants will be instructed to follow their standard diabetes care at SDCC or at SDCC-
Gentofte Hospital where they are treated during the study period. This usually includes up to three 
visits with a diabetologist (endocrinologist) and up to three visits with a diabetes nurse during a 
course of up to 12 months. Participants will be instructed not to have any further dietary counselling 
by a dietitian, and not to participate in any other courses or clinical intervention studies during the 
study period. The type and dose of glucose and lipid lowering medication may be changed during the 
study period as judged by the participants’ diabetologist. At the follow-up visit (week 48) the total 
number of visits at a diabetologist and diabetes nurse, and changes in type and dose of glucose and 
lipid lowering medication and other changes of medication during the follow-up period will be 
registered. 

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9.3.4 Dietary compliance 
Dietary adherence will be measured by three days of weighed dietary foods records and four days of 
urine samples. Participants in the BCC intervention group will also be instructed to keep a diary on 
how often their meals deviate from their personal carbohydrate meal plan. 
 
Dietary adherence is an important issue and also a measure indicating feasibility of the nutrition 
education method. Biomarker technologies have been developed for objective assessment of dietary 
compliance in recent years (35, 36). Several different sugars exist in carbohydrate rich foods and 
some of them have been shown to be excreted in urine in proportion to intake (37). Intake of several 
carbohydrate rich foods including total fruit and vegetables (38) and some whole grain foods (39) 
have been found to result in excretion of marker compounds in urine, while several others are under 
investigation. The excretion products may therefore be used as additional qualitative biomarkers of 
carbohydrate rich food intakes.  
 
9.4 Recruitment of participants 
SDCC offers courses in BCC for all patients with T2D treated at SDCC and SDCC-Gentofte Hospital.   
Patient information regarding the BCC courses is available on the SDCC webpage under the headline 
“Kurser” (https://www.sdcc.dk/undersoegelse-og-behandling/kurser/Sider/default.aspx), on info 
screens and posters and flyers in the waiting areas in each of the diabetes outpatient clinics at SDCC 
and SDCC-Gentofte Hospital. In addition, health care professionals (doctors, nurses and dietitians) 
from SDCC and SDCC-Gentofte Hospital can refer eligible patients to the BCC courses directly 
through the electronic medical record (EMR) “Sundhedsplatformen”. Information about the courses 
in the BCC concept has been given at meetings and as written materials (handouts and electronic 
newsletters) to health care professionals at SDCC and SDCC-Gentofte Hospital. 
  
The BCC courses are free of charge and online registration through a link or by e-mailing the course 
administrator is possible from SDCC’s webpage (sdcc.dk). By online registration or email, the 
patients indicate that they are interested in further contact for the purpose of being signed up for a 
course. Subsequently, a course administer at SDCC will contact all interested or referred patients by 
telephone to arrange a date for course participation, which is then registered in Sundhedsplatformen.  
 
Potential participants for the current study will be recruited among patients signing up for the BCC 
course or among patients directly referred to the BCC course by their health care professional. As part 
of the first telephone contact by the course administrator, the patients will be asked if they are 
interested in further information about a current study regarding the BCC course. In addition, 
potential eligible participants at the outpatient clinic at SDCC are identified by transferred 
information from the EMR about diagnosis, diabetes duration, age, sex, type of glucose-lowering 
treatment, HbA1c, previous participation in carbohydrate counting courses, time and number of 
previous dietitian visits and comorbidities by the primary study investigator. If potentially eligible, the 
treatment responsible health care personnel will ask the patients at the upcoming visit if they are 
interested in participation. Subsequently, the responsible care personnel will inform the study 
investigator about which patients were interested in participation and the study investigator/personnel 
will then contact these patients and send the written patient information together with the leaflet 
“Forsøgspersoners rettigheder i et sundhedsvidenskabeligt forskningsprojekt” (appendix 2) by mail 
or e-mail. Identified patients who do not have an appointment at the clinic in near future, will be 
contacted by a letter or by a secured e-mail (E-boks) with the written information. Potential study 
participants will be recruited through information on sdcc.dk and other electronic media (e.g. 
sundhed.dk, forsøgsperson.dk, diabetes.dk and social media), patient related networks (e.g. the Danish 
Diabetes Association) with a short description of the study and contact information for further details. 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
16 
 
Patients interested in participating in the study will be contacted by phone by the study investigator or 
study personnel who will offer to send written patient information about the study. If the patients are 
still interested in participation after having read the written patient information, the study investigator 
or study personnel who have been delegated the task according to the delegation log, will arrange for 
a personal meeting to provide oral information about the study (cf. below in section 9.6).   
 
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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9.5 Study participants 
The study will include adult patients with T2D with an initial HbA1c between 53 and 97 mmol/mol. 
The following specific inclusion and exclusion criteria are applied. 
 
9.5.1 Inclusion criteria  
• 
Patients with type 2 diabetes treated at SDCC or SDCC-Gentofte 
• 
Age; from ≥18 to ≤75 years of age 
• 
Diabetes duration; from >12 months 
• 
Diet or any glucose-lowering medication  
• 
Provided voluntary written informed consent 
 
9.5.2 Exclusion criteria  
• 
Practicing carbohydrate counting, as judged by the investigator 
• 
Participated in a BCC group program within the last two years 
• 
Use of an automated bolus calculator for carbohydrate counting, as judged by the investigator 
• 
Gastroparesis 
• 
Pregnancy or breastfeeding, or plans of pregnancy within the study period 
• 
Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day)  
• 
Uncontrolled medical issues, as judged by the investigator  
• 
Concomitant participation in other clinical studies  
• 
Unable to understand the informed consent and the study procedures 
 
9.5.3 Criteria for withdrawal 
One or more of these criteria will result in withdrawal of the participant from the study: 
• 
A participant withdraws the informed consent  
• 
Pregnancy or other safety concerns, as judged by the investigator  
• 
A participant’s general condition contraindicates continuing the study as judged by the 
investigator or a medical expert 
• 
Non-compliance with the study protocol or lack of corporation, as judged by the investigator 
• 
Lost to follow-up 
• 
Other reasons determined by the investigator 
 
Participation in the study is voluntary, and participants have the right to withdraw from the study at 
any time without providing a reason and with no loss of benefits to which the participant is entitled. If 
a participant chose to withdraw the study personnel and investigator must be informed immediately, 
and every effort should be made to complete the early termination assessments and document the 
reason for discontinuation. For participants considered lost to follow-up, the last completed visit will 
be recorded. The investigator has the right to terminate participation of any participant at any time if 
they deem it in the participant’s best interest. Study participants will not be excluded from the study if 
they do not attend all visits. Participants who withdraw from the study will not be replaced. Follow-up 
will be performed for withdrawn participants at the end of the study and used in analyses if allowed 
by the participant. 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
18 
 
9.6 Participant information  
Written, informed consent will be obtained from all participants prior to entry into the study. The 
study investigator /study personnel will contact all interested patients by phone and provide 
information about the study. If the patient is interested in participating in the study, the study 
investigator/study personnel will send the written patient information (appendix 1) and the leaflet 
“Forsøgspersoners rettigheder i et sundhedsvidenskabeligt forskningsprojekt” (appendix 2) by mail 
or e-mail. If the patient is still interested in study participation after having read the written patient 
information, the study investigator /study personnel will schedule a personal meeting with the patient, 
offering the possibility of bringing a confidant. At the personal meeting the study objectives, 
significance, content and requirements including risks and implications of the study and principles for 
randomization with allocation to either one of two interventions or a control group will be orally 
explained.  
 
In particular the patient will be informed about the following: 
• 
The possibility of withdrawing from the study at any time without losing any patient-related 
benefits  
• 
How personal and health-related data will be collected and used during the study 
• 
That all personal and health-related data will be anonymized 
 
The patient will be given time to discuss any questions and will be informed that he/she has at least 24 
hours to decide on participation in the study. If the patient decides to participate in the study right 
away, the patient and the study investigator/study personnel will sign the written informed consent, 
and the investigator/study personnel will perform a screening to assess if the patient is eligible for 
inclusion in the study (see section 9.7 for screening procedure). Patient eligible for inclusion in the 
study will be booked for a visit (V1) where the baseline measurements and randomization will be 
carried out by the study investigator/study personnel. If the patient needs more time to decide if he/she 
wants to participate in the study, the study personnel will contact the patient again within the next 
week. If the patient decides to participate in the study after having had time for reflection, the patient 
will be invited to a first visit (V1) with the purpose of screening for study eligibility, collection of 
baseline measurements and randomization. The patients are informed that written informed consent 
will be obtained prior to commencement of any study related procedures.  
  
 
9.7 Screening procedure and informed consent 
The study investigator/study personnel must receive a written signed consent (see appendix 4) from 
the patient before performing a screening. The signed consent form must also be signed by the 
investigator or study personnel who have been delegated the task according to the delegation log, and 
a copy of the signed consent must be handed over to the participant together with a copy of the patient 
information sheet before performing the screening. The original written signed consent will be 
retained by the study investigator. 
 
In addition, the patient will be asked to sign an independent written signed consent for donation of 
biologic material to a biobank for future research (see appendix 5). Rejection of donation of samples 
to the biobank, will not affect participation in the study. 
 
The investigator/study personnel will perform a screening to assess if the patient is eligible for 
inclusion in the study based on the inclusion and exclusion criteria listed in section 9.5.1 and 9.5.2. 
This includes having a non-fasting blood sample collected for assessment of HbA1c. The sample will 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
19 
 
be analysed instantly, and the result will be available in the patient’s EMR Sundhedsplatformen 
within 5-10 min for the investigator /study personnel to assess.  
 
The screening also includes a personal interview with the patient according to a study specific 
standard operational procedure (SOP) to assess the patient’s type of diabetes, place of standard care, 
age, diabetes duration, glucose lowering regime , use of continuous glucose monitoring (CGM), 
previous participation in a BCC course, existing carbohydrate counting practices including use of a 
bolus calculator, gastroparesis, daily intake of carbohydrates, current pregnancy or plans of 
pregnancy, breastfeeding, uncontrolled medical issues or concomitant participation in other clinical 
studies and language skills in Danish.  
 
If a participant is not eligible for inclusion in the study the cause of screening failure will be recorded, 
and the patient will be offered participation in the BCC course as a patient instead of as a study 
participant. 
 
9.8 Randomisation 
Participants eligible for inclusion in the study according to the screening will have the baseline 
measurements collected followed by a randomization carried out by the study investigator/study 
personnel.  
 
A total of 226 participants will be randomly allocated in a 1:1 ratio to one of the following groups:  
 
1) BCC  
2) Control  
 
Randomization will be performed by the investigator at visit 1 (V1) after the baseline examination. 
Participants will be randomly assigned to one of two groups with a 1:1 allocation by use of a 
computer-generated randomization schedule using the software system REDCap. The randomization 
list will be generated and kept securely by the clinical responsible investigator. The randomization is 
done by stratifying the participants based sex, BMI and HbA1c at baseline. The randomization is done 
in blocks to ensure an equal number of participants in each group.  
 
9.9 Patient outcome 
Expected patient outcomes are improved glycaemic control. All participants will be offered their 
personal study test results after they have completed the study period.  
 
9.10 Study feasibility 
SDCC has the facilities to carry out the study. SDCC has a kitchen for patient education called 
“FoodLab” designed to carry out group education programs with hands-on activities to practice food 
and self-management skills related to diabetes e.g. courses in BCC. 
 
Approximately 6,000 patients with T2D are treated at SDCC and SDCC-Gentofte Hospital and only a 
limited number of these patients have already attended an education program in BCC at SDCC. At 
least 15 courses in BCC are needed for education of 113 patients in the BCC group based on the 
assumption that we can recruit eight patients with T2D for each course not taking into account 
potential relatives and patients participating. During the last four years, 64 patients with T2D have 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
20 
 
attended the BCC program at SDCC. We will implement approximately 8 courses per year from 2018 
equal to 64 patients per year.  
 
One or two new courses in the BCC program will be initiated every third week at SDCC for patients 
with T2D except for holiday periods. Patients who do not wish to participate in the study or who do 
not fulfil the inclusion criteria will be included in the BCC courses together with BCC study 
participants. Additionally, some relatives will also be offered the opportunity to attend the BCC 
courses, if patients need extra support to manage dietary changes based on an individual assessment 
by the principle study investigator. 
 
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
21 
 
10 Examinations 
All patients found eligible for inclusion in the study will be invited to a first study visit (V1) for 
collection of baseline measurements up to four weeks before the intervention according to study 
specific SOPs. Subsequently, all participants will be randomized to one of the two study groups. All 
examinations will be performed in the outpatient diabetes clinic at SDCC. Study visits and 
examinations are described in detail in table 1 below and in the current section and section 11. 
Table 1: Schematic overview of study visits 
Visit no  
Time, week no from start of 
intervention  
Contact 
-8 to -4 
Scree
ning 
V1 
-4 to 
-1 
V2 
0-2 
V3 
4-12 
V4 
14-20 
V5 
24 
V6 
48 
Described 
in section 
Participant-related 
information 
 
Study information 
X 
 
 
 
 
 
 
 
9.6 
Informed written consent 
 
X 
 
 
 
 
 
 
9.7 
Eligible for inclusion 
 
X 
 
 
 
 
 
 
9.7 
Randomisation 
 
X 
 
 
 
 
 
 
9.8 
Efficacy outcomes 
 
 
HbA1c 
 
X 
X 
X 
X 
X 
X 
X 
10.2 
Plasma lipids 
 
 
X 
 
 
 
X 
X 
10.2 
Body weight 
 
 
X 
X 
X 
X 
X 
X 
10.1 
Height 
 
 
X 
 
 
 
 
 
10.1 
Blood pressure 
 
 
X 
 
 
 
X 
X 
10.1 
Waist and hip circumference 
 
 
X 
 
 
 
X 
X 
10.1 
Blood samples, fasting 
 
 
X 
 
 
 
X 
X 
10.2 
Blood samples, non-fasting 
 
X 
 
X 
X 
X 
 
 
10.2 
Urine samples 
 
 
X 
 
 
 
X 
 
10.3 
CGM including PG for 6 days 
 
 
X 
 
 
 
X 
 
10.4 
DXA 
 
 
X 
 
 
 
X 
 
10.5 
Questionnaires & Forms 
 
 
F: 4-days dietary registration 
 
 
X 
 
 
 
X 
 
10.6 
Q: Carbohydrate estimation 
accuracy  
 
 
X 
 
 
 
X 
X 
10.7 
Q: Mathematical literacy  
 
 
X 
 
 
 
X 
X 
10.7 
Q: Diet-related quality of life 
 
 
X 
 
 
 
X 
X 
10.7 
Q: Perceived Competencies in 
Diabetes Scale 
 
 
X 
 
 
 
X 
X 
10.7 
Q: Health-Care Climate 
 
 
X 
 
 
 
X 
 
10.7 
Q: Treatment satisfaction  
 
 
X 
 
 
 
X 
X 
10.7 
Q: Demographic data 
 
 
X 
 
 
 
 
 
10.9 
Q: Physical activity  
 
 
X 
 
 
 
X 
X 
10.10 
Intervention 
 
 
Standard dietary counselling 
 
 
 
X 
X 
X 
 
 
9.3.1 
BCC* 
 
 
 
X 
X 
X 
 
 
9.3.2 
Abbreviations CGM=continuous glucose monitoring d=day; DXA=Dual-energy-X-ray absorptiometry; F=forms; 
no=number; PG=plasma glucose; Q=Questionnaire; V=visit.   
*BCC group only 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
22 
 
10.1 Clinical examination  
Body weight will be measured at all study visits. Measurements at visits V1 (baseline), V5 (week 24) 
and V6 (week 48) will be in a fasting condition and measurements at V2, V3 and V4 in a non-fasting 
condition. Height will only be measured and recorded at V1. Blood pressure, waist and hip 
circumference will be performed at visits V1, V5 and V6. Procedures will be conducted after 
appropriated training of study personnel involved in carrying out the procedures. 
 
Body weight will be measured with the participant wearing light indoor clothes and no shoes at the 
same calibrated scale at all visits after emptying the bladder. Two measurements are done, and both 
are noted to the nearest 0.1 kg. The average of the two measurements is used in further analysis. 
 
Height is measured using a wall-mounted stadiometer with the participants not wearing shoes and 
with the heels, buttocks and upper part of the back remaining in contact with the wall/back of the 
stadiometer. Two measurements are made and both results are noted to the nearest 0.1 cm. The 
average of the two measurements is used in further analysis. 
 
Waist circumference is measured halfway between the lowest point of the costal margin and highest 
point of the iliac crest at the end of expiration with the participant in a standing position. All 
anthropometric measurements are performed twice with the average of the two measurements used in 
further analysis. 
 
Hip circumference is measured at the level of the greater femoral trochanter; both are measured to 
the nearest 0.5 cm at the end of expiration with the participant in a standing position. All 
anthropometric measurements are performed twice with the average of the two measurements used in 
further analysis. 
 
Blood pressure is measured with the participant in sitting position after minimum 10 min of rest, not 
talking during the measurement. Blood pressure measurements are repeated three times separated by 
two min breaks. Mean values are calculated. 
 
10.2 Blood samples  
Participants must attend V1, V5 and V6 after 8-10 hours of fasting having consumed only water for 
collection of blood samples. A small venous catheter will be inserted in one of the participant’s arms 
for blood sampling which will be performed by a trained biomedical laboratory technician in the 
Clinical Biochemical Department at SDCC. The samples will be used for assessment of C-peptide, 
triglycerides, total cholesterol, HDL-C, LDL-C, very-low-density-lipoprotein cholesterol (VLDL-C), 
HbA1c, fasting glucose, 
haemoglobin, creatinine, albumin, potassium, sodium, alanine 
aminotransferase (ALAT), thyroid-stimulating hormone (TSH), leucocytes, thrombocytes, cobalamin 
and alkaline phosphatase according to standard procedure. No tobacco smoking is allowed in the 
morning before the visit. HbA1c will also be measured at the screening visit and visits V2, V3 and V4 
in a non-fasting condition. 
10.3 Urine samples  
At V1 and V5 the participants will be provided with oral and written instructions on how to collect 
urine samples as midstream urine spots four times daily (preferably in the morning, afternoon and 
evening) for four days (three of which are the same days as the participants record their dietary food 
intake, while wearing a CGM). Participants are asked to hand in the urine collection at V2 for 
baseline measurements and by mail or in person after V5. Urine samples are analysed for content of 
albumin and creatinine as well as excretion of biomarkers related to carbohydrate intake (sucrose, 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
23 
 
fructose, mannose and lactose) and qualitative markers of common groups of carbohydrate rich foods 
including vegetables, fruit, whole grain, and possibly potato, beet root, and rice. Participants are asked 
to hand in their urine samples in person to the laboratory at SDCC no later than one week after the 
urine collection.  
 
10.4 Continuous Glucose Monitoring  
The iPro®2 CGM system will be used. The CGM will be inserted under the skin on the lower part of 
the abdomen (under the umbilicus) by the investigator or study personnel at V1 and V5 for use in a 
period of six days. Participants will receive a glucometer together with oral and written instructions 
about how to measure glucose levels four times a day while wearing the CGM. Measurements are to 
be taken before breakfast, before lunch, before main evening meal and before bedtime. Participants 
are asked to hand in the CGM at V2 after baseline measurements and by mail or in person after six 
days of use after V5.  
 
10.5 Body fat distribution  
A DXA scan will be performed at V1 and V5 to measure body composition. A pregnancy test will be 
performed in all fertile women at V1 according to national requirements and procedures for X-ray 
equipment. At V5 a urine pregnancy test will be performed if a menstrual period is missed or if 
pregnancy is suspected. If the test is positive, the scan will not be conducted and the participation in 
the study is stopped immediately. The DXA scan will be performed in a fasting state with the 
participants only wearing light clothing and after emptying the bladder. The participant will lie still on 
a table while a machine arm passes over their entire body, which emits a high- and a low-energy X-ray 
beam. By measuring the absorption of each beam into parts of the body, readings for bone mineral 
density, lean body mass and fat mass will be obtained. The same device and software will be used for 
all participants throughout the study and must be calibrated according to manufacturer’s instructions. 
The DXA scan will be conducted by the investigator or study personnel that have completed the 
mandatory course for non-medical staff operating DXA. 
 
10.6 Dietary assessment  
Participants are asked to complete four days of weighed dietary food records after V1 and V5. 
Participants will receive oral and written instructions about how to record their food intake in the 
same four days as they collect their urine and while wearing a CGM, preferably on four consecutive 
days including three weekdays and one day in the weekend to capture a representative weekly diet for 
assessment of total energy and macronutrient intake. All food and beverages consumed during the 
three days of recording must be noted in a dietary registration form with as many details as possible 
which include recording of pre- and post-meal plasma glucose levels, physical activities and for 
insulin users - insulin type and dose taken are also recorded (appendix 6). The exact amount of the 
food should be determined preferably by weighing the food on a digital scale, but in situations where 
this is not possible (e.g. when dining out) the estimated portion size using household measurements or 
other well-defined units will be accepted. Participants are asked to hand in the dietary registration 
form at V2 for baseline measurements and by mail or in person after V5. Instructions will be giving 
by study personal with a nutritional background well trained in performing and assessing dietary food 
records. After receiving the dietary registration forms the records will be visually inspected 
immediately for clarification of possible misunderstandings. Subsequently, the nutrient intake based 
on the dietary records will be calculated using the software system Vitakost (Vitakost Aps, Kolding) 
where nutrient and energy calculations are based on the Danish national food database. The dietary 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
24 
 
food records are used to estimate total energy intake (kJ/d), total carbohydrate intake (g/day and 
g/meal) and total dietary fibre intake (g/d g/10 MJ). 
 
10.7 Questionnaires  
Questionnaires on diabetes diet-related quality of life questionnaire (DDRQOL) (appendix 7), 
Perceived Competencies in  Diabetes Scale (PCS) (appendix 8), Health-Care Climate Questionnaire 
(HCCQ) (appendix 9), accuracy in carbohydrate portion size estimation assessed by a carbohydrate 
photographic questionnaire (CPQ) (appendix 10), mathematical literacy based on a mathematical 
literacy test (appendix 11), and level of physical activity as assessed by International Physical Activity 
Questionnaire Short Form (IPAQ SF) (appendix 12) will be send out electronically through the 
software system REDCap before visits V1, V5 and V6. Participants preferring to fill in the 
questionnaires at the study site will be offered access to a tablet or laptop at SDCC and support by 
study personnel as needed. 
 
10.8 Electronic medical record data 
The following data from the participants’ EMR Sundhedsplatformen will be collected at V1. Changes 
in glucose- and cholesterol-lowering medications will be registered at visits V5 and V6 and total 
number of visits at a diabetologist and diabetes nurse during the study period will be registered at V6. 
 
• 
Type of diabetes 
• 
Gender 
• 
Date of birth 
• 
Smoking status  
• 
Diabetes duration 
• 
Gastroparesis 
• 
Prescribed insulin, types and dosages 
• 
Prescribed oral antidiabetics, types and dosages  
• 
Prescribed cholesterol lowering medication, types and dosages 
• 
Prescribed other medication and dose or changes in dose of other medication   
• 
Participation in BCC group program previously 
• 
Use of open CGM 
• 
Use of a Free Libre  
• 
Use of an automated bolus calculator 
 
10.9 Other baseline demographics 
The following self-administered questions on baseline demographics will be sent out electronically 
before V1 using the software system REDCap (appendix 13). 
• 
Educational level 
• 
Main occupation 
• 
Use of mathematics in their current or previous profession or in their spare time  
• 
Civil status and household composition 
• 
Yearly income 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
25 
 
10.10 Physical activity level 
Physical activity level will be assessed using IPAQ SF (appendix 12). Participants will be encouraged 
to continue their habitual level of physical activity and not to change it during the 24 weeks study 
period. IPAQ SF will be send electronically before visits V1, V5 and V6. 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
26 
 
 
11 Study visits 
The following section describes all visits included in the study. The visits are also schematically 
presented in table 1. The visits will be conducted by the principle study investigator and study 
personnel under responsibility of the principle investigator. Examinations are described in section 10. 
For logistical reasons, windows are allowed for the study visits (± 21 days). A detailed visit flow for 
the study groups is presented in Figure 2.  
  
 
 
 
 
 
 
Figure 2 Visit flow 
BCC=basic Carbohydrate counting; BP= blood pressure; BW=body weight; CGM=continuous glucose 
monitoring; DXA=dual-energy-X-ray absorptiometry; V=visit 
 
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
27 
 
11.1 Study information 
The following procedures will be performed in the following order: 
• 
Short oral patient information by phone  
• 
Written patient information 
• 
Personal meeting for thorough oral patient information  
• 
Invitation to participate in the study after the patient has had time for reflection (at least 24 hours) 
11.2 Screening 
• 
A signed informed written consent has been collected before continuing 
• 
A non-fasting blood sample for assessment of HbA1c (screening criteria) 
• 
Screening for study eligibility according to inclusion and exclusion criteria,  
• 
If not eligible for inclusion the cause of screening failure is recorded and explained to the patient 
• 
Participants eligible for inclusion will be registered with an ID code  
• 
Randomization will be performed before the participant is sent home 
 
11.3 V1: Baseline (week -4 to -1) 
At visit 1 the following procedures and assessments will be performed in the morning after 8-10 hours 
fast: 
• 
Collection of fasting blood samples  
• 
Measurement of height, body weight, blood pressure, hip and waist circumference (fasting) 
• 
Pregnancy test (woman only) 
• 
Full body DXA scan (fasting condition) 
• 
A meal is provided for the participant 
• 
Fill in questionnaire concerning demographic data, CPQ, Mathematical literacy test, DDRQOL, 
PCS, HCCQ, IPAQ SF at V1  
• 
Collection of medical history including registration of glucose- and lipid-lowering medicine 
• 
Instruction in how to fill out the three days of dietary registration forms  
• 
Instruction in how to collect four days of urine sample and how to hand in the sample 
• 
Injection of CGM device and instruction in precautions and how to hand in the CGM 
• 
Instruction in recording four daily PG measurements in six days with CGM 
 
11.4 V2: Start of intervention, day 1 (week 0) 
At visit 2 the following procedures and assessments will be performed: 
• 
Measurement of body weight and HbA1c (non-fasting condition)  
• 
Update of glucose- and lipid-lowering medicine 
• 
Standard individual dietary counselling  
 
11.4.1. V2A: Start of intervention, day 1 (week 2) (BCC only) 
At visit 2A the following procedures will be performed for participants randomized to the BCC group: 
• 
Day 1 of BCC program in groups according to curriculum 
This visit will take place ±14 days compared to V2  
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
28 
 
11.5 V3: intervention, day 2 (week 12) 
At visit 3 the following procedures and assessments will be performed: 
• 
Measurement of body weight and HbA1c (non-fasting condition)  
• 
Update of glucose- and lipid-lowering medicine 
• 
Standard individual dietary counselling follow-up  
 
11.5.1. V3A: intervention, day 2 (week 4) (BCC only) 
At visit 3A the following procedures will be performed for participants randomized to the BCC group: 
• 
Day 2 of BCC program in groups according to curriculum 
For logistical reasons the visit will take place ±21 days compared to V2A 
 
11.6 V4: intervention, day 3 (week 20) 
At visit 4 the following procedures and assessments will be performed: 
• 
Measurement of body weight and HbA1c (non-fasting condition)  
• 
Update of glucose- and lipid-lowering medicine 
• 
Standard individual dietary counselling  
 
11.6.1. V4A: intervention, day 3 (week 14) (BCC only) 
At visit 4A the following procedures will be performed for participants randomized to the BCC group: 
• 
Day 3 of BCC program in groups according to curriculum 
For logistical reasons the visit will take place ±21 days compared to V3A 
 
11.7 V5: After 24 weeks of intervention  
At visit 5 the following procedures will be performed in the morning after 8-10 hours fasting: 
• 
Collection of fasting blood samples  
• 
Measurement of body weight, blood pressure, hip and waist circumference (fasting condition) 
• 
Check for pregnancy (women only) 
• 
Full body DXA scan (fasting condition) 
• 
A meal is provided for the participant 
• 
Participants who has not filled in all questionnaires before V5 will be asked to fill in at V5  
• 
Update of glucose- and lipid-lowering medicine 
• 
Instruction in how to fill out the three days of dietary registration forms  
• 
Instruction in how to collect four days of urine sample and how to hand in the sample 
• 
Injection of CGM device and instruction in precautions and how to hand in the CGM 
• 
Instruction in recording four daily PG measurements in six days with CGM 
 
11.8 V6: Follow-up at 48 weeks (24 weeks after intervention completion) 
At visit 6 the following procedures will be performed in the morning after 8-10 hours fasting: 
• 
Collection of fasting blood samples  
• 
Measurement of body weight, blood pressure, hip and waist circumference (fasting condition) 
• 
Update of glucose- and lipid-lowering medicine 
• 
Check total number of visits at a diabetologist and diabetes nurse during the study period 
• 
Participants who has not filled in all questionnaires before V6 will be asked to fill in at V6  
• 
A meal is provided for the participant 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
29 
 
12 Laboratory analyses  
12.1 Laboratory 
Laboratory analyses will be performed in the Department of Clinical Biochemistry at SDCC, Niels 
Steensens Vej 2, DK-2820 Gentofte. 
 
The current and emerging biomarkers of total carbohydrate intake and of carbohydrate-rich foods 
have been developed by University of Copenhagen (Preventive and Clinical Nutrition group, Dept. of 
Nutrition, Exercise and Sports (NEXS)) and others using equipment available at SDCC (Systems 
Medicine Group). 
 
12.2 Sample handling 
Blood samples will be drawn from all study participants as part of V1 to V6. Blood samples will be 
drawn and handed according to standard operational procedures (SOPs) specified by the Clinical 
Biochemical Department at SDCC which is responsible for the collection and analysis of the samples 
and storage locally until further data analysis. Blood samples in the study will be analysed 
immediately including plasma HbA1c at V1 in all potential participants since this measurement is 
used as part of the screening to assess if the patient in eligible for inclusion in the study. The total 
volume of blood drawn during the 48 weeks is a maximum of 186 ml, with 60 ml drawn at V1, V5 
and V6 including 3 x 10 ml for a biobank for future research, as specified in table 2. Any remaining 
samples and left over will be destroyed after conducting the analysis and storing of 30 ml for the 
biobank for future research. 
 
Table 2: Maximum volume of blood collected 
Visit number 
Week number 
Max blood volume (ml) 
Visit 1 
-4 to -1 
60 
Visit 2 
0 
2 
Visit 3 
12 
2 
Visit 4 
20 
2 
Visit 5 
24 
60 
Visit 6 
48 
60 
 
Urine will be collected as midstream urine spots four times daily (4 x 3 ml) for four days by the 
participants after V1 and V5 and will be analysed to estimate the  albumin-creatinine ratio and 
metabolomics analysis for excretion of biomarkers related to carbohydrate intake (sucrose, fructose, 
mannose and lactose) and qualitative markers of common groups of carbohydrate rich foods including 
vegetables, fruit, whole grain, and possibly potato, beet root, and rice and other intermediate 
metabolites at SDCC. After the return of urine collections at SDCC, these will be handed according to 
specific SOPs and stored until further data analysis for determination of metabolic profile 
(metabolomics analysis) at SDCC. The total volume of urine collected during the 48 weeks is 96 ml, 
with 48 ml being collected at each of the two visits (including 12 ml at V1 and V5 for a biobank for 
future research), as specified in table 3. 
 
Table 3: Maximum volume of urine collected 
Visit number 
Week number 
Max urine volume (ml) 
Visit 1 
-4 to -1 
48 
Visit 5 
24 
48 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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The collected blood and urine samples will be used for analysis in the study listed in Table 4.  
 
Table 4: Analysis of biochemical samples 
Visit 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Week 
-4 to -1 
0 
12 
20 
24 
48 
P-ALAT 
X 
 
 
 
X 
X 
P-Albumin 
X 
 
 
 
X 
X 
U-Albumin 
X 
 
 
 
X 
 
P-Alkaline phosphatase 
X 
 
 
 
X 
X 
P-C-peptide 
X 
 
 
 
X 
X 
P-Cobalamin 
X 
 
 
 
X 
X 
P-Creatinine 
X 
 
 
 
X 
X 
U-Creatinine 
X 
 
 
 
X 
 
P-Glucose 
X 
 
 
 
X 
X 
P-HbA1c 
X 
X 
X 
X 
X 
X 
P-HDL cholesterol 
X 
 
 
 
X 
X 
P-Haemoglobin 
X 
 
 
 
X 
X 
P-LDL cholesterol 
X 
 
 
 
X 
X 
P-Leucocytes 
X 
 
 
 
X 
X 
P-Potassium 
X 
 
 
 
X 
X 
P-Sodium 
X 
 
 
 
X 
X 
P-Thrombocytes 
X 
 
 
 
X 
X 
P-Total cholesterol 
X 
 
 
 
X 
X 
P-Triglyceride 
X 
 
 
 
X 
X 
P-TSH 
X 
 
 
 
X 
X 
P-VLDL cholesterol 
X 
 
 
 
X 
X 
Metabolomics analysis (urine) 
X 
 
 
 
X 
 
Biobank – plasma 
X 
 
 
 
X 
X 
Biobank – urine 
X 
 
 
 
X 
 
ALAT = Alanine aminotransferase; HbA1c = Glycosylated haemoglobin; HDL = High-density-lipoprotein; LDL = Low-
density-lipoprotein; TSH = Thyroid-stimulating hormone; VLDL = Very-low-density-lipoprotein.  
 
12.3 Storage of samples 
Urine samples in the study will be stored and analysed after the last patient’s last visit in the study, 
while blood and urine samples specifically collected for the biobank for future research will be stored 
in -80 degrees freezer at SDCC, Niels Steensens Vej 2, DK-2820 Gentofte.  
12.4 Samples for a research biobank and a biobank for future research 
A research biobank will be established for some of the samples specified in the current protocol. The 
aim of establishing the research biobank is to store urine samples from the participants for 
biochemical analysis after the last patient’s last visit in the study. The samples will be kept until 
31.12.2022 where the final analysis and study will be finished. At visits V1 and V5 urine samples of 
maximum 48 ml will be collected (96 ml in total during the study period) and stored in the research 
biobank. Any urine left in the research biobank after all relevant biochemical measurements have 
been performed will be destroyed.  
 
In addition to the research biobank, a biobank with additional blood and urine samples from the 
participants for use in future research within the area of diabetes not specified in the present protocol 
will be established. The donation of the additional blood and urine samples for a future biobank is 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
31 
 
voluntary and, will not affect the participants further, as the blood is drawn together with the blood 
samples drawn as part of the study and urine spots are collected in the same days as urine is collected 
as part of the study. Hence it will not cause an additional burden on the patient. A total of 30 ml blood 
will be drawn (10 ml at V1, V5 and V6) and a total of 24 ml urine will be kept (12 ml at V1 and V5) 
and stored in freezer at SDCC, Niels Steensens Vej 2, DK-2820 Gentofte. Donation of samples to the 
biobank for future research is voluntary, and the participants will be asked to sign an independent 
informed consent regarding donation of samples to the biobank for future research. Rejection of 
donation of samples to the biobank, will not affect participation in the study. Acceptance from the 
Danish Data Protection Agency will be sought in a separate application for the biobank for future 
research. Before samples from the biobank for future research can be used, a study protocol will be 
submitted for approval by an Ethics Committee. Blood and urine samples and associated data from the 
research biobank and the biobank for future research belong to the study investigators. 
 
 
 

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13 Statistical methods and determination of sample size 
13.1 Calculations 
The average changes after week 24 and 48 in primary and secondary outcomes will be calculated for 
each of the three groups. Results will be presented as means (SD) for normally distributed variables 
and as medians (inter-quartile range) for non-normally distributed variables. 
13.2 Statistical methods 
Intention-to-treat (ITT) analysis will be performed as the primary analysis on all primary and 
secondary outcomes after the last participant has participated in the last visit. Missing values will be 
handled with a last observation carried forward approach for ITT analysis. Per-protocol (PP) analysis 
will only be performed in case of sensitivity testing.  
 
Parametric tests (general linear models) will be used to test differences in outcomes from baseline to 
follow-up. Heterogeneity in responsiveness to the interventions will be tested by dividing each 
intervention group into smaller groups based on data distribution (medians) or clinically meaningful 
cut-points. If model assumptions cannot be met even after logarithmic transformation, non-parametric 
tests will be used. Plots of residuals versus predicted values will be used to judge normality. 
Metabolic patterns will be tested with multivariate statistics. Adjustment for relevant confounders will 
be performed. Two-sided tests will be used. P values of <0.05 are considered significant. The 
statistical programs SPSS and SAS will be used for data analysis.  
 
13.3 Determination of sample size 
Allowing for drop-outs (~30%) and subgroup analyses we plan to include a total of 226 patients in our 
study. This is based on sample size calculations which suggested that including 87 participants in each 
of the study groups would give us 80% power to detect a clinically meaningful difference in change in 
HbA1c of 3.0 mmol/mol between the BCC group versus the control group with a 5% significance 
level using a two-sided test and an estimated standard deviation (SD) of 7 mmol/mol. This SD and 
dropout rate have previously been used for sample size calculations and were similar to what we 
found when evaluating our BCC courses on dropout rate, mean changes and SD of HbA1c after 6 
months in completers with T2D. MAGE has only been used as an outcome measure of glucose 
variability in a few randomized controlled dietary intervention studies of patients with diabetes (40, 
41) showing differences in changes in MAGE up to 4.8 mmol/l (SD: 1.0) after a 12-week 
carbohydrate counting intervention (40). By including 113 participants in each study group we will 
have a power of 80% (alpha level of 0.05) in a two-sided test to detect a clinically meaningful 
difference in the change in MAGE during the intervention period (24 weeks) of ≥0.30 mmol/l (SD 0.7 
mmol/l) between the study groups as presented in Table 5. 
 
Table 5: Sample size calculations  
Difference in HbA1c, 
mmol/mol (SD 7.0) 
 
Difference in MAGE, 
mmol/l (SD 0.7) 
 
Net no of participants in 
the study (BCC vs control) 
No of participants 
given a dropout 
rate of 30%  
2.0 
0.20 
388 
504 
3.0 
0.30 
174 
226 
3.5 
0.35 
128 
166 
4.0 
0.40 
100 
130 

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14 Data management 
14.1 Data handling and quality assurance 
Before initiating the study, acceptance from the Danish Data Protection Agency will be sought. All 
health-related matters and sensitive personal data will be handled in accordance with the Danish “Act 
on Processing of Personal Data”. All health-related matters and sensitive personal data (blood test 
result etc.) will be depersonalized. All participants will be given a study number referring to their 
personal information, which will be stored securely and separately. Adequate blinding of all personal 
data during data processing and publication will be ensured. Data will be stored in coded form in 10 
years after last participant has attended the last visit, where after the data will be fully anonymised. 
 
14.2 Source data identification and verification 
All clinical study information in the study will be recorded, handled, and stored in a way that allows 
accurate reporting, interpretation and verification. All questionnaire data will be collected 
electronically using the software system “REDCap” according to local standards for research projects 
in the capital region of Denmark. In addition, all sources will be registered in this database. Data 
generated and stored for specific equipment (e.g. DXA data stored in the database in relation to the 
software used for the DXA scanner), EMR data (blood and urine measurements, glucose- and lipid-
lowering medicine) from Sundhedsplatformen, data from iPro®2  CGM using software from 
Medtronic (Northridge, CA, US) to download CGM measurements, data on use of carbohydrate meal 
plan from a diary and dietary data on total energy and nutrients based on calculations from the 
software system Vitakost where dietary recordings are entered will be added to the database in 
REDCap on an ongoing basis and at the end of study. Data is stored in coded form for 10 years. 
Hereafter, data will be fully anonymized.  
 
14.3 Data reporting and protection  
Data are owned by the investigators. The investigators are responsible for publishing the results. 
Positive and negative as well as inconclusive study results will be published by the investigators in 
international peer-reviewed journals, and all co-authors must comply with the Vancouver rules. The 
author order depends on the different authors’ contributions to the study. All information on study 
participants is protected according to law on processing of personal data and the law of health. None 
of the study-related blood samples or data will be stored or analysed in countries outside the EU.  
 
14.4 Study files  
The following documents will be present at SDCC before study initiation can take place: 
 
• 
Ethical approval of the protocol and informed consent document 
• 
Signed protocol page 
• 
Blank copy of the approved informed consent document and any other documents to the patients 
• 
CVs of principal investigator and co-investigators 
• 
Signed delegation log 
 
In addition, study specific SOPs, training logs, and case report forms will be prepared, and training 
sessions will be conducted to ensure standardization in relation to measurements taken before 
initiating the study recruitment of study participants. 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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Copies of all these documents as well as supplemental information, such as the final protocol will be 
kept at SDCC in an access restricted electronic trial master file. This file will also contain patient 
accountability records (screening and inclusion logs), correspondence with co-investigators and 
authorities, protocol deviations, and biological samples records. The investigator will keep a list of the 
patients, identifying the names (with identification number), their respective code number and the 
date of start of the study. All source documentation (i.e. medical notes, lab reports, etc.) will also be 
available in folders in coded form. The document identifying the patients by name and personal 
security number (CPR-number) will be kept in a separate folder with limited access which will be will 
be fully anonymized after 10 years.  
 
15 Ethics and regulations 
15.1 Independent ethics committee and regulatory authority 
The study protocol will be submitted for approval by the Ethics Committee of the Capital Region, 
Copenhagen and the study will be registered for approval of data storage at the Danish Data 
Protection Agency. After obtaining an approval from all authorities the study will be registered at 
clinical trials.gov and initiated. A report summarizing the results of the study will be sent to the Ethics 
Committee of the Capital Region after the study.  
  
15.2 Ethical conduct of the study 
The study will be conducted in accordance with the ethical principles in the Declaration of Helsinki 
and to the regulations for Good Clinical Practice (GCP) to the extent that this is relevant for a non-
medical study. The study will deliver important new knowledge on the effects of different dietitian-
led dietary interventions in patients with T2D in relation to glucose regulation and related metabolic 
parameters. In addition, the results from the study will give valuable information on patient self-care 
and adherence to their diabetes treatment through which the patients may experience reduced 
fluctuations in plasma glucose levels, including hypoglycaemia and increased diet-related quality of 
life. The findings from the study may have direct patient-related implications for future national 
guidelines and may potentially reduce the long-term diabetes-related complications.  
 
This non-pharmacological study has no obvious ethical concerns for the participants and only minor 
risks in relation to participation (please see section 15.3). The anticipated benefits for the participants 
are high including improved glycaemic control in terms of reduced HbA1c and plasma glucose 
variability as well as an improvement of diet-related quality of life and self-care. 
 
15.3 Risks related to participation 
Overall, limited risks are expected with the current study. All equipment used in the studies meet the 
requirements for patient safety and has previously been used in research projects without problems. 
There is a very small risk of hypoglycaemia at the study visits where participants must meet after an 
overnight fast of 8-10 hours for study measurements in a fasting state at three visits (V1, V5 and V6). 
In such cases the study investigator and study personnel will take appropriate action to protect 
participants. 
 
 
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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Blood samples 
Collection of data in the present study involves blood samples. A minor risk of slight pain during 
injection of the needle is present, and the sampling might leave a minor bruise at the place of 
injection. This will disappear within one to two days. Blood will be collected at four visits during the 
study period of 48 weeks corresponding to a total amount of 185 ml including 30 ml blood for a 
biobank for future research.  
 
CGM 
CGM will be used to measure the interstitial glucose at near continuous intervals to obtain a 24-hour 
glucose profile for a period of 6 days. The use of CGM involves insertion of a glucose sensor on the 
lower part of the abdomen (under the umbilicus) with an introducer needle to aid in the insertion of 
the sensor into the subcutaneous tissue. There is a minor risk of slight pain during injection of the 
needle. Also, a minor risk of skin irritation or infection due to either the sensor needle or the adhesive 
can occur.   
 
DXA 
DXA will be used for the assessment of body composition two times during the study. The scan is an 
x-ray examination, but the degree of radiation the participants will be exposed to during a scan is very 
limited with a radiation dose less than 0.001mSv. For comparison, the yearly background radiation in 
Denmark is 3 mSv, which accounts for daily radiation of 0.008 mSv. This corresponds to category 1 
in accordance with the classification based on the guidelines from the International Commission on 
Radiation Protection (ICRP) and the European Commission. This category corresponds to a stochastic 
damage by radiation exposure of normal research participants in the order of 1:1 million or less. This 
risk can be considered negligible. The scans will be conducted with an appropriate speed based on the 
body weight and sagittal diameter of the study participant. The scan is performed with the study 
participant lying on the back on an open scan couch while the arm of the scanner passes by. The scan 
takes approximately 15 minutes, and in case of a failure, only once extra scan will be performed. All 
fertile women will be asked to clearly state lack of pregnancy according to local requirements and 
procedures, and in case of statement the scan will not be conducted. 
 
15.4 Insurance of the patients 
Patients are covered under the Patient Insurance Act (Lov om klage- og erstatningsadgang inden for 
sundhedsvæsenet, lov nr. 1113 07/11/2011).  
 
15.5 Protocol changes 
Substantial amendments to this protocol may be implemented only after a favourable opinion of the 
Ethics Committee of the Capital Region, Copenhagen has been obtained. Amendments to the protocol 
are regarded as substantial if they have a significant impact on 
• 
The safety, physical health and mental integrity of the participants 
• 
The scientific value of the study 
• 
The conduct or the management of the study 
Any amendments to this protocol will be signed by the signatories included in section 2. If an event 
occurs related to the conduct of the study which may affect the safety of the participants, the study 
investigator may take appropriate measures to protect the participants against immediate hazards. The 
investigator will inform Ethics Committee of the Capital Region, Copenhagen of the new events and 
the measures taken as soon as possible.  

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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15.6 Protocol deviations 
No systematic deviations from the protocol are allowed, and no protocol waivers will be given. All 
protocol deviations noted during the study will be recorded and evaluated by the study investigator. 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
37 
 
16 Organisation 
16.1 Study tasks 
Research assistant and principle investigator: 
• 
Recruitment of study participants: Identification, telephone calls, screening 
• 
Study logistics including data collection and registration (e.g. no shows, new appointments) 
• 
iPro®2 for 6 days at V1 and V5 
• 
DXA scanning at V1 and V5 
• 
Instruction on urine collections and dietary recording at V1 and V5 
 
Principal investigator: 
• 
Data management, analysis and statistics 
• 
Writing of scientific papers based on the study 
 
Project dieticians 
 
BCC group education with dietitians Lotte Dencker and Pernille M Østergaard: 
• 
Carry out 15 courses (8-hours course) in BCC group ~ 120 hours (240 h with two educators)   
• 
Courses preparations (e.g. carbohydrate calculation plans): 1 hour per participant ~ 114 hours 
 
Standard dietary counselling with Lotte Vinter, Pernille M Østergaard or Sisse Larsen: 
• 
Carry out individual dietary counselling in intervention and control groups (n=226) ~ 452 hours    
 
Bio analyst: 
• 
Preparation of urine sampling kits  
• 
Handling of incoming urine samples for the research biobank and a biobank for future research  
• 
Collection of blood samples 
• 
Analysis of blood samples in the study and handling of blood samples for storage in a biobank for 
future research 
• 
Analysis of urine samples for albumin, creatinine and food intake biomarkers  
 
Post doc: 
• 
Support in sample analyses 
• 
Data analyses related to carbohydrate excretion and markers of carbohydrate rich foods  
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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17 Publication  
Positive as well as negative and inconclusive results of the study will be published in English in 
relevant peer-reviewed scientific journals as well as parallel Danish publications e.g. the journal for 
clinical dietitians, the Danish Diabetes Association’s journal for health care professionals and 
member’s journal and at the SDCC’s website. 
 
17.1 Authorship  
Bettina Ewers will be first and corresponding author, Jens M. Bruun second last author and Tina 
Vilsbøll last author. Other co-authors include Henrik Vestergaard, Filip K. Knop, Henrik U. 
Andersen, Helle Terkildsen Maindal and Lars Ove Dragsted. 
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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18 Study time-frame 
The active study period will begin with patient recruitment from August 2018 and expected to be 
finalized by October 2021. 
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
40 
 
19 Initiative and financing  
Head of Nutrition Bettina Ewers has taken initiative to this study together with Head of Clinic Tina 
Vilsbøll at SDCC and Professor Jens M. Bruun, NEXS, University of Copenhagen. 
 
The study has been partly funded by the Novo Nordisk Foundation as part of the non-standard 
initiatives (“Supplerende behandlingsinitiativer”) at SDCC in 2018-2020 to cover salary for dietitians. 
Salaries for the PhD-student, operating expenses and equipment are partly covered internally by the 
clinic and the clinical research at SDCC. Funding has been granted by the Beckett Foundation 
(150,000 DKR) and the Axel Muusfeldts Foundation (300,000 DKR) for salary for a research 
assistant. If further external funding is obtained, the Ethics Committee of the Capital Region, 
Copenhagen will be notified. The study investigators, study personnel and study dietitians have no 
economic benefits before, during and after the study. 
 
The requirements in Appendix 1 are fulfilled in accordance to the Ethics Committee of the Capital 
Region, Copenhagen ”Retningslinjer for vederlag og/eller andre goder til forsøgspatienter”. No 
economic compensation will be given to the study participants. Transportation to SDCC will be 
covered according to standard procedures for standard care at SDCC in patients eligible for transport. 
 

Protokol_TheBCCStudy_v8.0Final_080819 
 
 
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41. Tay J, Luscombe-Marsh ND, Thompson CH, Noakes M, Buckley JD, Wittert GA, et al. 
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21 List of appendices 
 
Appendix No 
Name of appendix 
 
Appendix 1 
 
Appendix 2  
 
Appendix 3 
 
Appendix 4 
 
Appendix 5 
 
Appendix 6 
 
Appendix 7 
 
Appendix 8 
 
Appendix 9 
 
Appendix 10 
 
Appendix 11 
 
Appendix 12 
 
Appendix 13 
Written patient information 
 
Forsøgspersoners rettigheder i et sundhedsvidenskabeligt projekt 
 
Guidelines for oral information 
 
Written consent form for study participation 
 
Written consent form for donation to a biobank for future research 
 
Dietary registration forms 
 
Diabetes Diet-Related Quality of Life (DDRQOL) questionnaire   
 
Perceived Competencies in Diabetes Scale (PCS)  
 
Health-Care Climate Questionnaire (HCCQ) 
 
Carbohydrate photographic questionnaire (CPQ) 
 
Mathematical literacy test 
 
International Physical Activity Questionnaire short form (IPAQ SF) 
 
Background questions