NCT01791907

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. 1.A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
  2. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

February 7, 2013

Last Update Submit

November 1, 2018

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quality of life

    1 year

  • CVD risk factors

    1 year

  • Hypoglycemia

    1 year

  • Food choices

    1 year

  • Health economics

    1 year

Study Arms (3)

Structured education in carbohydrate counting

EXPERIMENTAL

A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)

Behavioral: Structured education in carbohydrate counting

Structured education in healthy food choices and low GI

EXPERIMENTAL

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.

Behavioral: Structured education in healthy food choices and low glycemic index

Regular routine

NO INTERVENTION

Interventions

Structured education in carbohydrate countingBEHAVIORAL
Structured education in carbohydrate counting
Structured education in healthy food choices and low glycemic indexBEHAVIORAL
Structured education in healthy food choices and low GI

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mette Axelsen, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

July 1, 2017

Last Updated

November 5, 2018

Record last verified: 2018-11