AzTrials
AzTrials

Type1diabetesNCT03623113

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

A study testing BCC intervention, ABC-ACC intervention and Standard dietary education in people with Type1diabetes and Type1 Diabetes Mellitus, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes: 1. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BCC intervention, ABC-ACC intervention and Standard dietary education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteDenmark
Study dates
28 Sep 2018to 17 Aug 2022
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 1 diabetes
  • Diabetes duration; >12 months
  • HbA1c of 53-97 mmol/mol
  • Multiple daily insulin injection therapy
  • Provided voluntary written informed consent

Who cannot join

  • Practicing carbohydrate counting, as judged by the investigator
  • Participated in a BCC group program within the last two years
  • Use of insulin pump, or plans of having an insulin pump within the study period
  • Fixed dose of rapid acting insulin therapy for meals
  • Split-mixed insulin therapy
  • Use of open CGM
Show all 14Show fewer
  • Use of Freestyle Libre
  • Use of an automated bolus calculator
  • Gastroparesis
  • Pregnancy or breastfeeding, or plans of pregnancy within the study period
  • Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
  • Uncontrolled medical issues, as judged by the investigator or a medical expert
  • Concomitant participation in other clinical studies
  • Unable to understand the informed consent and the study procedures

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, DK-2820

Other trials in Denmark

About this study

Official title: The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study): A Randomized, Parallel, Open-label, Intervention Study Comparing Different Approaches to Dietary Self-management in Patients With Type 1 Diabetes

The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes:

  1. The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention)
  2. The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention)

The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.

Read the detailed description

The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care.

The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).

Being tested
BCC intervention, ABC-ACC intervention, Standard dietary education
Keywords
Carbohydrate counting, Basic carbohydrate counting, Advanced carbohydrate counting, Carbohydrates, Diet
Medical subject headings
Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCC interventionBehavioural

    Also called Basic carbohydrate counting

    Structured training and education i basic carbohydrate counting principles

  • ABC-ACC interventionBehavioural

    Also called Advanced carbohydrate counting with a bolus calculator

    Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate

  • Standard dietary educationBehavioural

    Also called Routine dietary care

    Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences

Study groups in NCT03623113
Study groupRoleWhat they receive
BCC interventionExperimentalThe BCC program consists of three group sessions and is delivered by two trained dietitians. In addition to the BCC program, the participants receive regular medical care in the diabetes clinic
Receives: Behavioral: BCC intervention
ABC-ACC interventionExperimentalThe ABC-ACC program consists of one group session and two individual follow-up sessions and is delivered by trained dietitians with supervision by a medical doctor. In addition to the ABC-ACC program, the participants receive regular medical care in the diabetes clinic
Receives: Behavioral: ABC-ACC intervention
Standard dietary educationActive comparatorThe routine outpatient dietary care consists of three individual consultations delivered by a trained dietitian. The individual guidance is based on the overall treatment goal(s), the defined personal dietary goals for behavioral change which will be in accordance with the patient's needs and preferences. In addition to the dietary counselling, the participants receive regular medical care in the diabetes clinic
Receives: Behavioral: Standard dietary education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    mmol/mol

    Measured: Baseline, 6 months

  2. Change in mean amplitude of glycaemic excursions (MAGE)

    mmol/l

    Measured: Baseline, 6 months

Secondary outcomes (31)

  1. Change in HbA1c

    mmol/mol

    Measured: 12 months

  2. Change in body weight

    kg

    Measured: Baseline, 6 months, 12 months

  3. Change in low-density lipoprotein cholesterol (LDL-C)

    mmol/l

    Measured: Baseline, 6 months, 12 months

  4. Change in high-density cholesterol (HDL-C)

    mmol/l

    Measured: Baseline, 6 months, 12 months

  5. Change in total cholesterol (TC)

    mmol/l

    Measured: Baseline, 6 months, 12 months

  6. Change in free fatty acids (FFA)

    mmol/l

    Measured: Baseline, 6 months, 12 months

  7. Change in triglycerides (TG)

    mmol/l

    Measured: Baseline, 6 months, 12 months

  8. Change in systolic blood pressure

    mm Hg

    Measured: Baseline, 6 months, 12 months

  9. Change in diastolic blood pressure

    mm Hg

    Measured: Baseline, 6 months, 12 months

  10. Change in waist circumference

    cm

    Measured: Baseline, 6 months, 12 months

  11. Change in hip circumference

    cm

    Measured: Baseline, 6 months, 12 months

  12. Change in total fat free mass

    gram

    Measured: Baseline, 6 months

  13. Change in total fat mass

    gram

    Measured: Baseline, 6 months

  14. Change in time in range (3.9-10.0 mmol/l)

    Percent (%)

    Measured: Baseline, 6 months

  15. Changes in % time spent in hypoglycaemia (<3.9 mmol/l)

    Percent (%)

    Measured: Baseline, 6 months

  16. Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)

    Percent (%)

    Measured: Baseline, 6 months

  17. Change in standard deviation of mean plasma glucose

    mmol/l

    Measured: Baseline, 6 months

  18. Change in mathematical literacy

    Total score or percent (%)

    Measured: Baseline, 6 months, 12 months

  19. Change in carbohydrate estimation accuracy

    Total score or percent (%)

    Measured: Baseline, 6 months, 12 months

  20. Change in diet-related quality of life

    Total score or percent (%)

    Measured: Baseline, 6 months, 12 months

  21. Change in perceived competences in diabetes

    Total score or percent (%)

    Measured: Baseline, 6 months, 12 months

  22. Change in degree of autonomy-supportive dietitian

    Total score or percent (%)

    Measured: Baseline, 6 months, 12 months

  23. Change in total energy intake

    kJ/day

    Measured: Baseline, 6 months

  24. Change in dietary intake of carbohydrates

    gram/day or percent of total energy (E%)

    Measured: Baseline, 6 months

  25. Change in dietary intake of total fat

    gram/day or percent of total energy (E%)

    Measured: Baseline, 6 months

  26. Change in dietary intake of saturated fatty acids (SFA)

    gram/day or percent of total energy (E%)

    Measured: Baseline, 6 months

  27. Change in dietary intake of monounsaturated fatty acids (MUFA)

    gram/day or percent of total energy (E%)

    Measured: Baseline, 6 months

  28. Change in dietary intake of polyunsaturated fatty acids (PUFA)

    gram/day or percent of total energy (E%)

    Measured: Baseline, 6 months

  29. Change in dietary intake of protein

    gram/day or percent of total energy (E%)

    Measured: Baseline, 6 months

  30. Change in dietary intake of added sugar

    gram/day or percent of total energy (E%)

    Measured: Baseline, 6 months

  31. Change in intake of dietary fibre

    gram/day or g/MJ

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2018
  2. Study start28 Sep 2018
  3. Primary completion17 Aug 2022
  4. Study completion17 Aug 2022

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03623113
Sponsor's protocol ID
H-18014897
Status last verified
Jan 2024
First submitted
19 Jul 2018
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ewers B, Vilsboll T, Andersen HU, Bruun JM. The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes. BMJ Open. 2019 Sep 3;9(9):e029859. doi: 10.1136/bmjopen-2019-029859.

    PubMed 31481560

Questions about this trial

What is this clinical trial studying?

A study testing BCC intervention, ABC-ACC intervention and Standard dietary education in people with Type1diabetes and Type1 Diabetes Mellitus, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

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 5 inclusion and 14 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 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change in HbA1c (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03623113, which also lists 1 linked publication.

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 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in