The Breakfast Rise, Education and Knowledge Study in Children and Young People Who Have Type 1 Diabetes (T1D): The BREAK Study
Phase: NA
Conditions: type1diabetes
Sponsor: University of Stirling

 
 
Page 1 Title: Study Protocol Summary  Date:  08/10/2022, Version 2, IRAS ID: 316676 
 
 
 
Project summary  
Type 1 diabetes (T1D) is a chronic disease which requires daily calculations of food intake 
and insulin dose adjustment to achieve good glycaemic control and minimise the risk of 
developing diabetic complications. However, even when glycaemic control appears to be 
good, as demonstrated by average glycated haemoglobin (HbA1c), children and young people 
with T1D frequently experience glucose variability, with levels above and below the target 
range. The main cause of diurnal glucose variability is food intake, which can cause 
postprandial hyperglycaemia. Postprandial hyperglycemia can occur after any meal, although 
there is some evidence that it may be worse after breakfast. There is limited data on the 
occurrence and cause of this and its association with different variables, including food 
composition and the glycaemic load of a meal.  
Methods:  
This project will be a quantitative study.  The study proposes to recruit 90 children and young 
people who have T1D and who regularly use Dexcom continuous glucose monitoring (CGM). 
Recruitment will be via their managing dietitian. The dietitian will be asked to provide baseline 
information about the participants which will include demographic data and information on 
clinical data, treatment and anthropometrics. Participants will be asked to provide access to 
Dexcom CGM data throughout the period of recording. Participants will be asked to test three 
breakfast meals (high glycaemic load, high glycaemic with 10g added protein and medium 
glycaemic load) plus a control meal (usual breakfast), repeating each meal twice in a 
randomized order using a Latin square randomisation. The dietitian will be asked to optimise 
the participants insulin doses prior to commencing test meals. Participants will be asked to 
complete a questionnaire for each of the postprandial test and control meal periods. This will 
include questions about their diabetes management, food and fluid intake in addition to 
questions on activities all of which took place during the three-hour postprandial period. The 
glycaemic response to the test and control meals will be analysed using the CGM data and 
the results statistically described using univariate, bivariate and multivariate analysis.   
 
   
 
 

 
 
Page 2 Title: Study Protocol Summary  Date:  08/10/2022, Version 2, IRAS ID: 316676 
 
 
  
Study protocol  
Full Study Title:  
The Breakfast Rise, Education and Knowledge Study in Children and Young People who have 
Type 1 Diabetes (T1D): The BREAK study.   
Short title 
The BREAK study. 
 
Summary Protocol, date: 08/10/2022, version number 2 IRAS ID:316676. NICR reference 
(8017) REC reference: 22/NS/0123 
 
 
Chief Investigator: 
Julie Johnson, University of Stirling and NHS Highland, 
julie.johnson1@stir.ac.uk, 07815893076 
Investigators:  
Professor Stuart Galloway, University of Stirling, Stirling FK9 4LA 
 s.d.r.galloway@stir.ac.uk. 01786 466494  
Professor Ashley Shepherd, University of Stirling, Stirling FK9 4LA 
ashley.shepherd@stir.ac.uk  01786 466334 
 
Statistical review:  
 
 
 
Professor Stuart Galloway, University of Stirling, Stirling FK9 4LA 
 s.d.r.galloway@stir.ac.uk. 01786 466494 
 
Lead Sponsor:  
Rachel Beaton, Research Integrity and Governance Manager, 
University of Stirling, Stirling FK9 4LA. Rachel.beaton@stir.ac.uk 
01786 466196   
Lead R&D  
Frances Hines, Research, Development and Innovation Manager, 
NHS Highland, Centre for Health Sciences, Raigmore Hospital, Old 
Perth Road, Inverness, IV2 3UJ. frances.hines@nhs.scot. 01463 
255822  
Funder: 
Ethics approval:  
NHS Highland  
This study has been reviewed and provided a favorable opinion by 
the NHS, Invasive or Clinical Research (NICR) Panel, University of 
Stirling and the North of Scotland (1) Research Ethics Committee 
has reviewed the study (REC Reference 22/NS/0123). 
 
 
 

 
 
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List of Contents 
Content  
Page Number 
 
 
Rationale 
4-6 
Aims & Objectives  
6 
Study Design 
6-8 
Methodology 
8-11 
Data Analysis  
Safety Considerations 
11 
11-12 
Data Management  
12-14 
Expected Outcome  
14 
Dissemination of Results 
14-15 
Ethical Considerations 
15 
Budget 
Insurance 
Proposed Timetable 
15 
15 
16 
Reference list 
17-19 
 
 
 
 
 
 

 
 
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Rationale 
Introduction  
Type 1 diabetes (T1D) is caused by autoimmune destruction of the beta-cells that secrete 
insulin (Eisenbarth, 1986; Bluestone et al. 2010). It requires life-long treatment of insulin 
therapy, with the aim to achieve near-normoglycaemia, gauged by the amount of glycated 
haemoglobin, or HbA1c concentration, there is in the erythrocytes (Bunn et al. 1978). This 
measurement of HbA1c, against a clinically 'desired' target (DiMeglio et al. 2018), is a gold 
standard element of diabetes management (DCCT, 1993) but as a mean measurement, it  
does not reflect the full pattern of glycaemia (Derr & Garrett, 2003) and cannot be used to 
foresee glucose variability (Boland et al. 2001). Even when HbA1c is in target, nocturnal and 
diurnal glucose variability, involving both hypo- and hyperglycaemia can be a daily occurrence 
for children and young people with T1D (Boland et al. 2001; Tansey et al. 2016). Data from 
continuous glucose monitoring (CGM) has shown that children experience nocturnal 
hypoglycaemia and diurnal hyperglycaemia, particularly postprandial hyperglycaemia (Boland 
et al. 2001; Tansey et al. 2016) and there is some evidence that this is worse after breakfast 
(Boland et al. 2001; Heptulla et al. 2004; Gandrud et al. 2007).  
Complications 
One of the reasons glucose variability and postprandial hyperglycaemia are a concern is that 
they both contribute to overall diabetes control (Standl et al. 2011). Poor glycaemic control 
causes cumulative and deleterious effects on both the cardiovascular (Koivisto et al. 1996) 
and microvascular systems (Kaiser et al. 1993). A further concern for children and young 
people, living with diabetes, is that they are vulnerable to alterations in glucose concentrations 
in the central nervous system owing to their high requirement for glucose for brain growth and 
development (Chugani et al. 1987). Several studies have observed alterations to both white 
and grey matter in children and adults with T1D (Perantie et al. 2007; Perantie et al. 2011; 
Marzelli et al. 2014; Mauras et al. 2015; Marziaka et al. 2016) and studies using CGM have 
observed an association with this and both glucose variability and hyperglycaemia (Marzelli et 
al. 2014; Barnea-Goraly et al. 2014; Mauras et al. 2015; Marziaka et al. 2016). Children with 
T1D often perform worse on cognition tests than those without the disease and decreases in 
IQ have been noted during periods of hyperglycaemia (Gonder-Frederick et al. (2009). T1D 
also appears to increase the risk of mental health difficulties (Butwicka et al. 2015) and this 
has been associated with hyperglycaemia (McDonnell et al. 2007).   
Glycaemic index and glycaemic load  
Postprandial hyperglycaemia following the breakfast meal has been shown to be associated 
with the glycaemic index of the meal consumed (Birnbacher et al. 1995). The glycaemic index 

 
 
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(GI), introduced by Jenkins et al. (1981), is based on the two-hour postprandial glucose 
response to a test carbohydrate food. A Cochrane review of the GI in diabetes populations 
(Thomas & Elliott, 2009) and a meta-analysis of glycaemic response to the GI of breakfast 
meals in healthy adults, (Toh et al. 2019) have demonstrated the lower glycaemic response 
after low GI meals. However, the evidence in paediatric diabetes is limited. A further limitation 
is that the GI fails to take account of the effect, on glycaemia, of other foods within a meal. A 
more accurate way to measure glycaemic response is to calculate the glycaemic load of a 
meal. This is calculated by multiplying the GI of each carbohydrate in a meal by the grams of 
available carbohydrate (Salmeron et al. 1997) within the meal. There appears to be a paucity 
of evidence for the impact of the glycaemic load of breakfast meals on postprandial glycaemia 
in children and young people who have T1D. 
Possible solutions to postprandial hyperglycaemia  
One method to establish the impact of glycaemic load on glycaemia is to utilise CGM data. 
CGM is able to identify postprandial hyperglycaemia because of the density of data it affords 
(Tansey et al. 2016; Mangrola et al. 2017).  CGM will likely help identify diverse responses to 
the myriad of dietary components (Bell et al. 2015) and thus CGM will likely allow for better 
prandial decision-making. As well as considering glycaemic load, another aspect of better 
prandial decision making may be found in dietary manipulation with protein. In those without 
diabetes, dietary protein intake is known to stimulate insulin production (van Loon et al. 2000). 
In children and young adults with T1D, 75g of protein consumed in isolation has a similar 
impact on blood glucose levels as 20g of glucose taken without insulin (Paterson et al. 2014). 
The glucose response to this amount of protein is however dissimilar to glucose as the rise in 
blood glucose is much slower with a later peak in glucose levels (Paterson et al. 2014). This 
suggests the addition of protein to a carbohydrate containing meal may help reduce 
postprandial hyperglycaemia by slowing the glycaemic response. 25g of protein has been 
shown to reduce postprandial glucose levels in the evening (Paterson et al. 2017).  
Although the additional of a moderate amount of protein to a carbohydrate containing meal is 
recommended in international guidelines (Smart et al. 2018) there appears to be no evidence 
for this as a prevention of postprandial hyperglycaemia at breakfast. It is agreed that further 
research into the dietetic management of T1D is required (Smart et al. 2018). There is also a 
dearth of evidence on prevalence and management of postprandial hyperglycaemia after 
breakfast. Seven studies tested meals at breakfast time (Ryan et al. 2008; Smart et al. 2012; 
Smart et al. 2013; Piechowiak et al. 2017; Faber et al. 2017; Lopez et al. 2018) however none 
of the aims of these studies were to establish prevalence nor resolution of postprandial 
hyperglycaemia at breakfast. Only two considered diet quality at breakfast (Ryan et al. 2008; 

 
 
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Groele et al. 2014) and neither of these provided any evidence of how to manage postprandial 
hyperglycaemia after breakfast.  
 
Conclusion  
It is known that chronic hyperglycaemia causes increased risk of diabetic complications. It is 
possible that both glucose variability and postprandial hyperglycaemia are independent risk 
factors for this as well. There is some evidence that glucose variability and postprandial 
hyperglycaemic are common occurrence for children who have T1D. However, there is a 
paucity of published data on the prevalence of postprandial hyperglycaemia after breakfast in 
children and young people with T1D and limited evidence for the impact of glycaemic load and 
manipulation with protein. The need for closer examination of postprandial glucose variability 
to elucidate methods to reduce this, has been highlighted (Tansey et al. 2016). Although this 
applies to all meals, focusing on minimising postprandial hyperglycaemia after breakfast is 
paramount. This can help ensure good control through the morning and rest of the day when 
children are at school and actively learning (Tansey et al. 2016). 
Aim: 
To describe the distribution and dispersion of glucose variability and postprandial 
hyperglycaemia following test and control meals at breakfast, in children and young people 
with T1D, using measurements from Dexcom CGM.  
Objectives:  
• 
To determine the glucose variability diurnally, nocturnally and in the three-hour 
postprandial breakfast test meal period using measurement of 8time in range9, 8time 
above range9 and 8time below range9.  
• 
To determine the variability of glucose excursion, level and peak and the recovery time 
in the three-hour postprandial period.  
• 
To describe comparisons between all the above measurements and the variables of 
sex, age, disease duration, BMI, HbA1c, insulin dose/sensitivity and insulin regimen.  
• 
To describe comparisons between all the above measurements and the glycaemic 
load and composition of the test and control meals. 
Study design  
This is a quantitative study. Dexcom CGM data will be collected for the period of recording. 
Participants will be asked to test three breakfast meals on two occasions and submit a 
postprandial questionnaire after each test meal to confirm it has been tested. The postprandial 
period will be three hours following the end of the breakfast test meal. The test meal recipes 

 
 
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will be provided by the chief investigator. The dietary composition of the meals has been 
analysed using the Nutritics dietary analysis programme (Nutritics, 2022). The glycaemic 
index and load of the meals is estimated from the Nutritics programme which uses available 
date from the international tables of glycaemic index and glycaemic loads (Atkinson et al. 
2008; 2021). Most foods were based on average composition across different brands. For the 
added fibre bread used in test meal 3, an average of three known brands was used calculated 
by the chief investigator.  The meals will be taken in the home environment with the food 
provided by the families. The participants will be asked to take the test meal on a day when 
their CGM reading is between 4-10mmol/l and when there has been no nocturnal 
hypoglycaemia on the night before the planned test. The participants will act as their own 
control. They will be asked to complete a postprandial questionnaire for control meals as well. 
The control meals will be there usual breakfast of choice. The study duration, commencing 
with the recruitment of the first participant and ending when data has been fully described, is 
anticipated to be two years.        
Participants  
Eligibility criteria  
• 
Children and young people aged between 5-17 years   
• 
Diagnosis of type 1 diabetes for a minimum of one year  
• 
On multiple daily injections (MDI) together with carbohydrate counting or Continuous 
Subcutaneous Insulin Infusion (CSII) using either open or closed loop systems. 
• 
Use Dexcom continuous glucose monitoring (CGM) on a regular basis 
• 
Have a Dexcom Clarity account and use the Clarity App  
• 
Regularly eats a breakfast meal before midday   
• 
Access to internet and email   
Exclusion criteria  
• 
Prescribed anti-hyperglycaemia agents i.e. Glucophage (Metformin) and or 
antidepressants. 
• 
Any other medical conditions that may impact on the digestion and or absorption of 
nutrients, including coeliac disease and gastroparesis. 
• 
Vegans  
• 
Allergic or intolerant to the test meals   
• 
Experiencing difficulties with food including diagnosed eating disorders 
• 
Currently actively taking part in another research study 
 
 

 
 
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Recruitment  
Paediatric diabetes dietitians, working across the UK, will be enrolled to help recruit 
participants and become principal investigators (PI) for their site. On enrolment, the chief 
investigator will provide the dietitians with all the relevant participant information sheets and 
consent forms as well as an Excel spreadsheet for entering the baseline information. The 
study documentation is presented in Appendices 1-9.  
 
Sample size 
The sample size power calculation is 64. This is based on using ANOVA repeated measures, 
within factors with four groups and measurements (3 test meals and control) with small effect 
size (0.15), P value 0.05 and power 0.80 and correlation among repeated measure of 0.5. The 
drop rate of clinical trials is often over 40%. Therefore, the aim is to recruit 90 participants to 
allow for this dropout rate and meet the sample size of 64. It may be possible to recruit this 
number of participants. There are approximately 29,000 children and young people living in 
the UK with T1D (Juvenile Diabetes Research Federation (JDRF), 2018). In the first phase of 
this study, 12 NHS sites were enrolled, and 96 children and young people were recruited to 
the study.  
 
Methodology 
Baseline data  
In order to make comparisons between relevant variables and glucose levels, the following 
baseline data will be collected from the dietitians and sent to the chief investigator, along with 
the artificial identifier on the Excel spreadsheet as discussed earlier at the stage of recruitment 
of participants:  
• 
Parent9s email address 
• 
Sex, date of birth and recent weight and height (for calculation of BMI and BMI centile) 
and date of when this was taken 
• 
Date of diagnosis of T1D 
• 
Last four HbA1c 
• 
Total daily insulin dose (TDD) 
• 
Insulin: carbohydrate ratios (ICR) and Insulin Sensitivity Factor (ISF)  
• 
Current insulin regimen - including the type of insulin prescribed and if applicable type 
of insulin pump i.e. open or closed loop system.  
 
 

 
 
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Run-in period  
At recruitment the dietitians will be asked to arrange a review of the participants insulin 
regimen including the insulin to carbohydrate ratio9s (ICR), insulin sensitivity factor (ISF) and 
basal background insulin doses/rates. The dietitian will be asked to inform the chief 
investigator when this has taken place. Participants will be asked to commence the test meals 
following this. 
Glucose measurement   
Data on interstitial glucose will be collected via Dexcom CGM. The Dexcom CGM data will be 
accessed by an NHS Highland research 8Clarity Clinic9 with Dexcom CLARITY® Clinic Portal 
(Dexcom In, San Diego, CA, USA). The chief investigator is administrator of this clinic. Once 
the managing dietitian has obtained each participant9s consent, the participant9s parent9s email 
address will be sent to the chief investigator along with the baseline information/data as 
described above. The chief investigator, as administrator of the Clarity Clinic account, will then 
invite the participant, via email, to be added to the clinic. Once the invite has been accepted, 
it will stand for the period of the recording i.e. until all the test meals and questionnaires have 
been completed. Once the participant has submitted their last questionnaire, they will be 
removed from the Dexcom CLARITY® Clinic Portal. They will be removed from the clinic portal 
if they withdraw from the study. 
Test and control meals  
Following the provision of CGM data and review of the insulin regimen by the diabetes team, 
participants will be randomised to test each of the three test meals on two separate occasions 
with a control meal (usual breakfast meal) for each test meal. Randomisation will be achieved 
using 
a 
Latin 
square 
randomisation. 
The 
tool 
used 
for 
this 
will 
be 
http://www.jerrydallal.com/random/randomize.htm. Randomisation will be done in a block of 
four.  
The test meals are based on foods children and young people enjoy eating. There are three 
meals. Test meal one includes a high glycaemic index cereal meal with milk and has a high 
glycaemic load (> 20), test meal two is the same cereal meal with a high glycaemic load (>20) 
with addition of 10g protein and test meal three has a medium glycaemic load (10-20). For 
test meals one and two there are three portion size options to meet age appropriate 
requirements and appetites. The participants will be able to choose from two different cereals 
for test meal 1 and a choice of protein sources for test meal 2. They will be asked to keep to 
the same choice of cereal and protein source for the repeat meal. They will be asked to 
consume at least 75% of the meal to ensure the threshold of the glycaemic load is met. The 

 
 
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instructions and details of the test meals are presented in Appendix 11. The control meals will 
be the participant9s usual breakfast of choice.  
Participants will be asked to follow their usual insulin regimen as advised by their diabetes 
team i.e. their usual insulin dose and dose timing. For both test and control meals participants 
will be asked to avoid any further food intake during three-hour postprandial period other than 
carbohydrate adjustments required to treat any hypoglycaemia. Participants will also be asked 
to avoid drinks except water or carbohydrate free juices. They will also be asked to avoid 
physical activity of more than 30 minutes in duration. To minimise disruption to their normal 
daily activities, they will be advised to test the meal on a day when there is no planned physical 
activity i.e. a school day with no morning physical education. The CGM data will be collected 
throughout this time as discussed above.  
Postprandial Questionnaire 
The participants will be asked to complete a postprandial questionnaire using 8online survey9. 
This includes questions about the meal and the three-hour postprandial period. The 
questionnaire is presented in Appendix 10. They will be asked to wait a minimum of three 
hours before answering and submitting the questionnaire.  They will be encouraged to 
complete it on the same day as the test or control meal.  
Outcome measures 
Primary and secondary outcome measures will be based on international guidelines and 
consensus DiMegloi et al. 2018; Battelino et al. 2019) of the metrics and target glucose levels 
to be used in CGM analysis in clinical practice. These are agreed to be: 
Metrics: 
• 
Mean glucose  
• 
Glucose variability (GV) % coefficient of variation (COV) target ≤36% 
• 
Time in range (TIR) % and time spent between 3.9-10mmol/l 
• 
Time above target (TAR) % and time spent >10.1-<13.9mmol/l) and >13.9mmol/l 
• 
Time below range (TBR) % and time spent 3.0-3.8mmol/l and <3mmol/l  
Target glucose levels:  
• 
TIR - % of readings >70% or 16hr 48min 
• 
TAR - % of readings <25% or <6hr high and <5% 1hr 12min very high  
• 
TBR- % of readings <4% or <1hr low and <1% or <15min very low     
Primary outcome measure:  

 
 
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• 
Mean glucose (mmol/l) in the three-hour postprandial breakfast period calculated from 
the CGM measurements at 5 minutes intervals.   
Secondary outcome measures – post prandial period:   
• 
Number and percentage who had pre-prandial glucose in target, mean peak glucose 
level (mmol/l), mean time to peak (mins), mean time to recover (to pre-prandial levels) 
(mins) in the three-hour postprandial breakfast period 
• 
TIR, TBR and TAR (% and time) in the three-hour postprandial breakfast period  
• 
Comparisons of the above measurements between cohorts and breakfast test meal 
compositions.  
Data analysis  
This will be a mix of univariate, bivariate and multivariate analysis as this is best suited to 
describing, summarising and visualising these data. Outputs will include the distribution of 
glucose levels post-breakfast to determine the spread and dispersion of the data.  
Safety considerations  
Recruitment/consent 
 
Assent and parental consent will be obtained for the participants who are aged under 16 years. 
Where possible consent should be taken face to face. However, consent can be taken 
electronically. This will involve the dietitians meeting with the families either virtually or via 
telephone to go through the study and read through the consent form. As per the HRA/MRC 
Consent and Participant Information guidance, 8electronic methods for documenting consent 
can be considered to be in writing9. The dietitian should provide a copy of the signed consent 
form to the participant and this can be sent electronically. Electronic signature can be a simple 
electronic 
signature 
which 
can 
be 
a 
typed 
name 
(http://www.hra-
decisiontools.org.uk/consent/glossary). Consideration will be given to those potential 
participants/families who are experiencing difficulties managing their condition, for example 
8diabetes burnout9; poor glycaemic control or other stressors, for example, family difficulties, 
stress at school, for example, dealing with bullying or exam pressures. This will be minimised 
by recruiting via the managing dietitian who will have significant knowledge of the potential 
participant and who will be expected to discourage recruitment, if it is felt the family have 
enough to cope with. Those who are newly diagnosed will not meet the eligibility criteria as it 
is felt this would be unethical given the pressure they will be experiencing dealing with a new 
diagnosis of a chronic disease. Participants will not be asked to change their usual diabetes 
management. Participants will not be expected to eat the breakfast meal if it is something they 
do not like. Rather than adjusting their postprandial activities, participants will be asked to test 
the meals on days when they have less than 30minutes of exercise planned.  The postprandial 

 
 
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period is three hours in order that most participants will be able to partake in their usual mid-
morning snack as it is anticipated this will be more than three hours after the end of breakfast. 
 
Personal data collection  
 
Personal data as described above will be collected and will be securely managed. How this 
will be managed is described in the 8Data Management9 section. 
 
Burden on dietitians  
 
The dietitians will need to be allowed additional time to recruit participants. Dietitians will be 
asked to discuss this with their line managers and gain their approval for this and with their 
diabetes teams. Although the dietitians will be asked to optimise the participants insulin 
management prior to them commencing the test meals this is part of their usual diabetes 
management and could be undertaken by another member of the diabetes team at a routine 
appointment.  
 
Burden on families 
The meals are based on foods that are commonly eaten by children and young people and 
that is easily accessible and affordable and, in some cases, may already be available in the 
household without additional cost implications. The time required to read the instructions is 
minimised by using flowcharts. Additionally, the time required to complete the questionnaires 
is minimised by utilisation of digital technology to ensure that completion of questionnaire 
surveys is not too time consuming.  
 
Data management  
Assessment of existing data  
There appears to be a dearth of available data on the distribution and dispersal of glucose 
levels in children and young people who have T1D. Nor does there appear to be any published 
data comparing glucose measurements from Dexcom CGM with different breakfast 
compositions in children and young people with T1D. The project is therefore not creating new 
data when existing data could be re-used.    
Creation of new data   
This will include the following: 
• 
Dexcom CGM measurements of interstitial glucose when testing meals at 
breakfast time.  
• 
Information on activities and adjustments in the three-hour postprandial period as 
discussed earlier. 

 
 
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Methods of anonymisation, pseudonymisation and encryption 
None of participants names and addresses will be collected. Surnames are likely to be known, 
owing to the need to obtain email address for the CGM data collection. The participants date 
of birth is required for the Dexcom Clarity clinic. Password for the Pseudonymisation will take 
place as recommended by GDPR regulation (General Data Protection Regulation (GDPR) 
2018). Artificial identifiers, to be used for all communication and data storage, will be provided 
for each participant at the stage of recruitment. All data, including parent9s email addresses, 
will be stored on an NHS Highland secure remote server which is password protected with 
files encrypted. Breeches of data will be reported through both the Data Management 
Committee (see below) and the NHS Highland incident reporting system (DATIX).  
Collection, storage and transfer of data - baseline information  
Baseline information will be collected by the participant9s managing dietitians, taken from 
diabetes clinical records. These data will be pseudonymised with the artificial identifier and 
entered on an Excel spreadsheet, by the enrolled dietitian and communicated via 8NHS mail9 
(see Appendix 1) to the Chief Investigator. Only the Chief Investigator will have access to this 
information. This information includes the participants date of birth. 8NHS mail9 is accredited to 
government official status for sharing patient identifiable and sensitive information and meets 
the secure email standard (DCB1596). All data, including the participants date of birth, will be 
stored on the NHS Highland server.  
 
Collection, storage and transfer of data - Dexcom CGM data  
The chief investigator in administrator of the NHS Highland research clinic on Dexcom CGM 
Clarity which is accessed via the internet and is password and username protected. The chief 
investigator will then invite the participants, via their parent9s email address, to join the clinic. 
This a standard way of accessing Dexcom CGM data. The invite will include the artificial 
identifier, and this is the identifier that will be visible when the data is accessed and not the 
name of the participant. For the invite to work it must include the participant9s date of birth for 
verification purposes. Email addresses and date of birth will be recorded in the baseline 
information spreadsheet and this will be stored on the NHS Highland laptop. Dexcom have 
their own security management and personal information is transmitted in encrypted form. 
CGM data will transferred to a CSV file, saved as an Excel file and stored on an NHS Highland 
laptop. An example of this in presented in Appendix 12. As consumers of Dexcom CGM the 
participants will have access to the Dexcom, Inc Privacy Policy which complies with the 
GDPR) 2016. 
(https://www.dexcom.com/en-GB/linked/documentservice/PrivacyPolicy).    
 

 
 
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Collection, storage and transfer of data - survey questionnaires  
The researcher plans to use Jisc 8Online Surveys9 (formerly BOS). The University of Stirling 
subscribes to this service and the researcher has a unique username and password for 
accessing this, known only to the researcher. Jisc is registered with the Information 
Commissioners Office (ICO) (registration number Z9546606) and meets the requirements of 
GDPR (https://www.onlinesurveys.ac.uk/gdpr-and-online-surveys/) and is certified to ISO 
27001 (https://www.jisc.ac.uk/about/certification ). All survey responses are collected over 
encrypted SSL (TLS) connections. The university GDPR statement is added to all the survey 
questionnaires. Responses to the survey will be transferred to a CSV file then saved as an 
Excel file on the NHS Highland laptop.  
 
Collection, storage and transfer of data - Nutritional analysis 
The control breakfast meals will be analysed using Nutritics or similar diet analysis programme 
which will be accessed via an NHS Highland desktop. Only details of the food will be entered 
into the programme. The analysis will be transferred to a CSV file, saved as an Excel file and 
emailed via NHS mail to be saved on the NHS Highland laptop. 
 
Data ownership 
It is anticipated that new data, arising from the study, and the associated intellectual property 
will be owned jointly by the University of Stirling and NHS Highland with a sharing agreement.  
 
Destruction of data  
The Dexcom Clarity clinic only stores CGM data for three months. Once these data have been 
collected for the period of the study, the Dexcom research clinic will be closed. Any transferred 
data will be stored on the NHS Highland secure remote server for 10 years before being 
deleted. Personal data (emails addresses, artificial identifiers, dates of birth will be deleted 6-
12 months after the study ends).    
Definition of end of study 
The study will end when all the participants have completed the test and control meals and 
submitted their questionnaire responses and their CGM data for the period of the meals has 
been exported and they have been removed from the Clarity clinic.  
Expected outcomes  
The aim of this study is to describe the distribution and dispersion of glucose variability and 
postprandial hyperglycaemia after test meals at breakfast and establish comparisons of these 
between variables obtained from baseline information and nutrient analysis. It is hoped this 

 
 
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will provide evidence of the impact of high and medium glycaemic load breakfast meals have 
on glycaemic response in children and young people who have T1D. It is also hoped the study 
will provide evidence of the impact additional protein has on glycaemic response when taken 
as part of a mixed high glycaemic load meal.      
This will increase the knowledge of diabetes educators, patients and families and ensure 
diabetes education includes evidence-based information on how to minimise postprandial 
hyperglycaemia at breakfast time.     
Dissemination of results  
It is anticipated that one paper will be submitted for publication. The proposed journals for 
publication include:  
• 
Pediatric Diabetes 
• 
Diabetic Medicine 
• 
Diabetologia 
• 
Diabetes Technology & Therapeutics 
• 
Acta Diabetologica.    
Ethical considerations 
This study has been reviewed and provided a favorable opinion by… to be added when 
obtained  
Consent will be obtained from parents and/or carers and, where appropriate, the children and 
young people themselves. As Principal Investigators, the recruiting dietitians will be asked to 
encourage, where possible, the children and young people to be involved in the decision to 
participant in the study. The dietitians will therefore be asked to ensure conversations 
regarding the study be discussed when the child/young person is present. It should be noted 
that in Scotland, children over the age of 12 years old are usually considered to be mature 
enough to give a view about taking part in research even if they are not fully able to give 
consent. The recruiting dietitians will be asked to discourage parents from consenting to 
participate if their child expresses either verbally or non-verbally that they do not wish to 
participate.  
Budget 
Only participants already self-funding or receiving NHS funding for Dexcom CGM will be 
recruited therefore there will no cost for using Dexcom CGM. The University of Stirling already 
subscribe to www.onlinesurveys.ac.uk.  The NHS Highland laptop is already available to the 
researcher. Funding will be applied for with the aim to provide some backfill for the researcher 
to undergo some of the research during work time.   

 
 
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Insurance  
The University of Stirling provide indemnity insurance although the risk of adverse events is 
low given that participants will be asked to follow their usual diabetes management as advised 
by their diabetes team.  

 
 
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Proposed timetable  
 
 
 
Task                                                      
May-22
Jun-22
Jul-22
Aug-22
Sep-22
Oct-22
Nov-22
Dec-22
Jan-23
Feb-23
Mar-23
Apr-23
May-23
Jun-23
Jul-23
Aug-23
Sep-23
Oct-23
Nov-23
Dec-23
Jan-24
Feb-24
Mar-24
Apr-24
Jun-24
Jul-24
Aug-24
Sep-24
Oct-24
Nov-24
Dec-24
Jan-25
Feb-25
Mar-25
Apr-25
Review of proposal
NICR application
Ethics application
Enrolling Dietitians
Recruit participants 
Analysis data
Write up analysis 
Submit above for publication 

 
 
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