Diabetes Mellitus, Type 1NCT01791907
Effect of Structured Nutrition Education in Type 1 Diabetes
A study testing Structured education in carbohydrate counting and Structured education in healthy food choices and low glycemic index in people with Diabetes Mellitus, Type 1, run by Göteborg University.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Structured education in carbohydrate counting and Structured education in healthy food choices and low glycemic index
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Nephropathy (dU albumin> 300 mg / d)
- Retinopathy (grade> 2)
- Foot ulcers
- Gastroparesis
- Difficulties visiting the hospital
- Current or planned pregnancy during the study period
Show all 9Show fewer
- ≥ 14 days fast during the study period
- Having partaken in education in carbohydrate counting (≥ 4 hours) in the last two years
- No computer access
About this study
Official title: Effect of Structured Education in Advanced Carbohydrate Counting or Healthy Food Choices With Low Glycemic Index in Type 1 Diabetes
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:
Read more
- A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
- 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Structured education in carbohydrate counting, Structured education in healthy food choices and low glycemic index
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured education in carbohydrate countingBehavioural
Structured education in healthy food choices and low glycemic indexBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Structured education in carbohydrate counting | Experimental | A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating) Receives: 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. Receives: Behavioral: Structured education in healthy food choices and low glycemic index |
| Regular routine | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The primary outcome measure is to detect a clinically significant difference in HbA1c (= 4.2 mmol / mol) between the three treatment arms
Measured: 1 year
Secondary outcomes (5)
Quality of life
Secondary measures is to demonstrate a difference between the groups in terms of quality of life
Measured: 1 year
CVD risk factors
Secondary measures is to demonstrate a difference between the groups in terms of CVD risk factors
Measured: 1 year
Hypoglycemia
Secondary objectives is to demonstrate a difference between the groups in terms of hypoglycemia
Measured: 1 year
Food choices
To demonstrate a difference between the groups in terms of food choices
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Axelsen, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791907
- Sponsor's protocol ID
- EPN 304-12
- Status last verified
- Nov 2018
- First submitted
- 7 Feb 2013
- Last updated
- 5 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Education in Advanced Carbohydrate Counting or Healthy Food Choices With Low Glycemic Index in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01791907
- Acronym / sponsor ID
- EPN 304-12
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured education in carbohydrate counting | Experimental | Behavioral: Structured education in carbohydrate countingA structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating) |
| Structured education in healthy food choices and low GI | Experimental | Behavioral: Structured education in healthy food choices and low glycemic indexA 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. |
| Regular routine | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having type 1 diabetes
- Diabetes duration > 3 years
- Age 20-70 years
- BMI <35 (kg/m2)
- Multiple dose injection (MDI) therapy
Key exclusion criteria (9 listed)
- Nephropathy (dU albumin> 300 mg / d)
- Retinopathy (grade> 2)
- Foot ulcers
- Gastroparesis
- Difficulties visiting the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured education in carbohydrate counting | Behavioural | Structured education in carbohydrate counting |
| Structured education in healthy food choices and low glycemic index | Behavioural | Structured education in healthy food choices and low GI |
Primary outcome
HbA1c
Time frame: 1 year
The primary outcome measure is to detect a clinically significant difference in HbA1c (= 4.2 mmol / mol) between the three treatment arms
5 secondary outcomes
Quality of life
Time frame: 1 year
CVD risk factors
Time frame: 1 year
Hypoglycemia
Time frame: 1 year
Food choices
Time frame: 1 year
Health economics
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Axelsen, PhD principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
A study testing Structured education in carbohydrate counting and Structured education in healthy food choices and low glycemic index in people with Diabetes Mellitus, Type 1, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.