Effect of Structured Nutrition Education in Type 1 Diabetes

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01791907
Study type	Interventional
Source	Göteborg University
Contact
Status	Completed
Phase	N/A
Start date	February 2013
Completion date	July 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04030091` - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus	Phase 4
Terminated	`NCT03605329` - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS	N/A
Completed	`NCT01696266` - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting	`NCT06050642` - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.	N/A
Completed	`NCT05107544` - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes	N/A
Active, not recruiting	`NCT04443153` - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes	N/A
Completed	`NCT04521634` - Glycaemic Variability in Acute Stroke
Completed	`NCT04569994` - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes	Phase 1
Completed	`NCT04089462` - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study	N/A
Completed	`NCT03143816` - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study	Phase 4
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A
Completed	`NCT04042207` - Diabeloop for Highly Unstable Type 1 Diabetes	N/A
Not yet recruiting	`NCT06068205` - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting	`NCT05909800` - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.	Phase 2
Active, not recruiting	`NCT04974528` - Afrezza® INHALE-1 Study in Pediatrics	Phase 3
Completed	`NCT04530292` - Home Intervention and Social Precariousness in Childhood Diabetes	N/A
Completed	`NCT05428943` - OPT101 in Type 1 Diabetes Patients	Phase 1
Recruiting	`NCT03988764` - Monogenic Diabetes Misdiagnosed as Type 1
Completed	`NCT05597605` - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects	N/A