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Type2 DiabetesNCT03623139

Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes

A study testing Standard nutritional education and Basic carbohydrate counting in people with Type2 Diabetes and Diabetes Mellitus, Type 2, 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
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Trial summary

The aim of the study is to examine the health benefits of adding a concept in basic carbohydrate counting (BCC) to the routine outpatient nutritional education for adult patients with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Standard nutritional education and Basic carbohydrate counting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteDenmark
Study dates
28 Sep 2018to 16 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 2 diabetes
  • Diabetes duration; from >12 months
  • HbA1c between 53 and 97 mmol/mol
  • Diet or any glucose-lowering medication
  • 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
  • Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
  • Use of open CGM
  • Use of a Free Libre device
  • Use of an automated bolus calculator for carbohydrate counting, as judged by the investigator
Show all 11Show fewer
  • Gastroparesis
  • Pregnancy or breastfeeding, or plans of pregnancy within the study period
  • Uncontrolled medical issues, as judged by the investigator
  • 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

    Herlev, DK-2730

Other trials in Denmark

About this study

Official title: Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education: A Randomized Controlled Trial Focusing on HbA1c and Glucose Variability in Patients With Type 2 Diabetes (The BCC Study)

The aim of the study is to examine the health benefits of adding a concept in basic carbohydrate counting (BCC) to the routine outpatient nutritional education for adult patients with type 2 diabetes.

The study hypothesis is that training and education in the BCC concept will improve glycaemic control either by reducing HbA1c or the average plasma glucose variability more than offering the routine dietary care as a stand-alone dietary treatment.

Read the detailed description

The trial has a parallel-group design with a study duration of 48 weeks for each participant (a 6-month intervention period and a 6-month follow-up period). A total of 226 patients will be enrolled in the trial. Participants will be randomized to one of two arms: 1) Standard medical and dietary care (control group) or 2) Structured training and education in the BCC concept in addition to standard medical and dietary care.

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

Being tested
Standard nutritional education, Basic carbohydrate counting
Keywords
carbohydrates, basic carbohydrate counting, diet, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders

What participants receive

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

  • Standard nutritional educationBehavioural

    Also called Routine dietary care in type 2 diabetes

    Routine dietary care consists of three individual consultations with a trained dietitian. The individual guidance will be in accordance with the dietary guidelines in type 2 diabetes.

  • Basic carbohydrate countingBehavioural

    Also called Education in BCC in addition to standard dietary care

    The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.

Study groups in NCT03623139
Study groupRoleWhat they receive
Standard nutritional educationActive comparatorControl group
Receives: Behavioral: Standard nutritional education
BCCExperimentalEducation and training i basic carbohydrate counting (BCC) plus standard nutritional education
Receives: Behavioral: Basic carbohydrate counting

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 diastolic blood pressure

    mm Hg

    Measured: Baseline, 6 months, 12 months

  9. Change in systolic 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 %

    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 , % of total energy or %

    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 completion16 Aug 2022
  4. Study completion16 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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03623139
Sponsor's protocol ID
H-18014918
Status last verified
Apr 2023
First submitted
18 Jul 2018
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ewers B, Bruun JM, Vilsboll T. Effects of basic carbohydrate counting versus standard outpatient nutritional education (The BCC Study): study protocol for a randomised, parallel open-label, intervention study focusing on HbA1c and glucose variability in patients with type 2 diabetes. BMJ Open. 2019 Nov 21;9(11):e032893. doi: 10.1136/bmjopen-2019-032893.

    PubMed 31753900

Questions about this trial

What is this clinical trial studying?

A study testing Standard nutritional education and Basic carbohydrate counting in people with Type2 Diabetes and Diabetes Mellitus, Type 2, 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 11 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 27 Apr 2023. 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 NCT03623139, 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 27 Apr 2023.

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