Effect of Structured Nutrition Education in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Effect of Structured Education in Advanced Carbohydrate Counting or Healthy Food Choices With Low Glycemic Index in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791907
• Other study ID #: EPN 304-12
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: July 2017

Study information

• Verified date: November 2018
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Structured education in carbohydrate counting

• Structured education in healthy food choices and low glycemic index

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	The primary outcome measure is to detect a clinically significant difference in HbA1c (= 4.2 mmol / mol) between the three treatment arms	1 year
Secondary	Quality of life	Secondary measures is to demonstrate a difference between the groups in terms of quality of life	1 year
Secondary	CVD risk factors	Secondary measures is to demonstrate a difference between the groups in terms of CVD risk factors	1 year
Secondary	Hypoglycemia	Secondary objectives is to demonstrate a difference between the groups in terms of hypoglycemia	1 year
Secondary	Food choices	To demonstrate a difference between the groups in terms of food choices	1 year
Secondary	Health economics	A secondary objective is to demonstrate a difference between the groups in terms of health economics and compare cost- effectiveness of the treatment arms	1 year