Glucose Metabolism Disorders, Type1diabetes, Type1 Diabetes Mellitus
Conditions
Keywords
Carbohydrate counting, Basic carbohydrate counting, Advanced carbohydrate counting, Carbohydrates, Diet
Brief 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. 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.
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).
Interventions
BEHAVIORALBCC intervention
Structured training and education i basic carbohydrate counting principles
BEHAVIORALABC-ACC intervention
Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate
BEHAVIORALStandard dietary education
Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences
Sponsors
University of Copenhagen
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Diabetes duration; \>12 months * HbA1c of 53-97 mmol/mol * Multiple daily insulin injection therapy * Provided voluntary written informed consent
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline, 6 months | mmol/mol |
| Change in mean amplitude of glycaemic excursions (MAGE) | Baseline, 6 months | mmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hip circumference | Baseline, 6 months, 12 months | cm |
| Change in total fat free mass | Baseline, 6 months | gram |
| Change in HbA1c | 12 months | mmol/mol |
| Change in body weight | Baseline, 6 months, 12 months | kg |
| Change in low-density lipoprotein cholesterol (LDL-C) | Baseline, 6 months, 12 months | mmol/l |
| Change in high-density cholesterol (HDL-C) | Baseline, 6 months, 12 months | mmol/l |
| Change in total cholesterol (TC) | Baseline, 6 months, 12 months | mmol/l |
| Change in free fatty acids (FFA) | Baseline, 6 months, 12 months | mmol/l |
| Change in triglycerides (TG) | Baseline, 6 months, 12 months | mmol/l |
| Change in systolic blood pressure | Baseline, 6 months, 12 months | mm Hg |
| Change in diastolic blood pressure | Baseline, 6 months, 12 months | mm Hg |
| Change in waist circumference | Baseline, 6 months, 12 months | cm |
| Change in total fat mass | Baseline, 6 months | gram |
| Change in dietary intake of added sugar | Baseline, 6 months | gram/day or percent of total energy (E%) |
| Changes in % time spent in hypoglycaemia (<3.9 mmol/l) | Baseline, 6 months | Percent (%) |
| Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l) | Baseline, 6 months | Percent (%) |
| Change in standard deviation of mean plasma glucose | Baseline, 6 months | mmol/l |
| Change in mathematical literacy | Baseline, 6 months, 12 months | Total score or percent (%) |
| Change in carbohydrate estimation accuracy | Baseline, 6 months, 12 months | Total score or percent (%) |
| Change in diet-related quality of life | Baseline, 6 months, 12 months | Total score or percent (%) |
| Change in perceived competences in diabetes | Baseline, 6 months, 12 months | Total score or percent (%) |
| Change in degree of autonomy-supportive dietitian | Baseline, 6 months, 12 months | Total score or percent (%) |
| Change in total energy intake | Baseline, 6 months | kJ/day |
| Change in dietary intake of carbohydrates | Baseline, 6 months | gram/day or percent of total energy (E%) |
| Change in dietary intake of total fat | Baseline, 6 months | gram/day or percent of total energy (E%) |
| Change in dietary intake of saturated fatty acids (SFA) | Baseline, 6 months | gram/day or percent of total energy (E%) |
| Change in dietary intake of monounsaturated fatty acids (MUFA) | Baseline, 6 months | gram/day or percent of total energy (E%) |
| Change in dietary intake of polyunsaturated fatty acids (PUFA) | Baseline, 6 months | gram/day or percent of total energy (E%) |
| Change in dietary intake of protein | Baseline, 6 months | gram/day or percent of total energy (E%) |
| Change in time in range (3.9-10.0 mmol/l) | Baseline, 6 months | Percent (%) |
| Change in intake of dietary fibre | Baseline, 6 months | gram/day or g/MJ |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary biomarkers of carbohydrate intake | Baseline, 6 months | Percent (%) |
| Change in physical activity level | Baseline, 6 months, 12 months | Total score or percent (%) |
Countries
Denmark
Outcome results
None listed