Clinical trial NCT01791907: Effect of Structured Nutrition Education in Type 1 Diabetes
Official title: Effect of Structured Education in Advanced Carbohydrate Counting or Healthy Food Choices With Low Glycemic Index in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 181
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 1 diabetes (T1DM) is a chronic disease that affects approximately 10% of all diabetes patients in the world. Diabetes a serious disease in which life expectancy is reduced, largely due to increased mortality from kidney disease and cardiovascular (CVD) disease. Poor glycemic control also results in eye and nerve damage, and psychosocial stress. Good metabolic control, e.g. normalized hemoglobin levels (HbA1c) and normal blood lipids, reduces the risk of eye, kidney, nerve, and vascular damage. Proper nutrition can normalize blood sugar levels, improve blood lipids and prolong life in people with diabetes, according to Swedish Council on Health Technology Assessment (SBU).

Dietary treatment is therefore seen as pivotal in the treatment of diabetes. This project aims to evaluate two methods of structured training in patients with type 1 diabetes:

1. A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
2. A new, structured education for heart healthy food choices and low glycemic index in type 1 diabetes. The education is called "My Wellness-LADDER" (Lifelong Adult Diet \& Diabetes Education Resource) and it is specifically designed to provide high long-term adherence through improved empowerment and transformative life style change.

The methods are compared with regular routine (control group).

This is a randomized controlled trial with three intervention groups 1) Healthy food choices with a low glycemic index, 2) carbohydrate counting, and 3) regular routine. Follow-up period is 1 year. Eight Swedish specialist clinics are participating and 24 patients at each clinic are to be enrolled.

The hypotheses is that structured group education on heart healthy food choices and low glycemic index provide the same improvement in glycemic control and quality of life as advanced carbohydrate counting in T1DM, as compared to regular routine. An additional hypotheses is that structured education on healthy food choices and low glycemic index leads to larger CVD risk factor reductions in T1DM compared to carbohydrate counting and regular routine and that structured education on healthy food choices and low glycemic index lead to more heart healthy food choices in T1DM compared to carbohydrate counting and regular routine. Lastly, the hypotheses is that structured education on healthy food choices and low glycemic index lead is more cost effective in T1DM compared to carbohydrate counting and regular routine.


Eligibility criteria: Inclusion Criteria:

* Having type 1 diabetes
* Diabetes duration \> 3 years
* Age 20-70 years
* BMI \<35 (kg/m2)
* Multiple dose injection (MDI) therapy
* HbA1c 57-78 mmol/mol
* Being healthy other than diabetes
* Autonomous accommodation and having influence over one's own food choices.
* Have given informed consent to participate in the study, as well as having the ability of oral and written communication in Swedish.

Exclusion Criteria:

* Nephropathy (dU albumin\> 300 mg / d)
* Retinopathy (grade\> 2)
* Foot ulcers
* Gastroparesis
* Difficulties visiting the hospital
* Current or planned pregnancy during the study period
* ≥ 14 days fast during the study period
* Having partaken in education in carbohydrate counting (≥ 4 hours) in the last two years
* No computer access

Primary outcomes:
measure: HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
measure: CVD risk factors
timeFrame: 1 year
measure: Hypoglycemia
timeFrame: 1 year
measure: Food choices
timeFrame: 1 year
measure: Health economics
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Göteborg University
name: Mette Axelsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: