Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Dietary intervention, CGM, continuous glucose monitoring
Brief summary
The primary aim of this pilot study is to assess the feasibility of a 12-week dietary intervention combined with the use of CGM in adults with T2D. The results of the pilot study will provide insights into recruitment, design, and the effectiveness of the intervention for the future long-term (12-month) PRECISE-DIET STUDY
Detailed description
In recent decades, there has been a significant rise in the development and use of glucose lowering drugs aimed at improving glycemic control in individuals with type 2 diabetes (T2D). Despite medical advancements, more than one-third of the danish population with T2D have a hemoglobin A1c (HbA1c) exceeding the recommended thresholds. One limiting factor in supporting individuals achieve their glycaemic target may be driven by substantial postprandial increases in plasma glucose levels, which is influenced by the quantity and type of carbohydrates in meals, underscoring the critical role of dietary interventions as an integral component of T2D management. Recent studies have demonstrated that the use of continuous glucose monitors (CGMs), which allow individuals to track their glucose profiles continuously throughout the day, improves glycemic control in T2D patients. However, these studies often exclude dietary interventions, which could potentially yield greater improvements in blood glucose regulation. Nutritional research in recent years has focused on dietary patterns such as low-fat diets, the paleo diet, and vegan diets. Nevertheless, these studies have not sufficiently addressed individualized dietary adjustments to mitigate postprandial glucose excursions, despite their substantial importance for glycemic control. Several clinical studies have revealed significant inter-individual variations in glycemic responses to identical standardized meals, highlighting the necessity of a personalized approach to dietary recommendations, particularly with a focus on carbohydrate intake. The primary aim of this pilot study is to assess the feasibility of a 12-week dietary intervention combined with the use of CGM in adults with T2D. The results of the pilot study will provide insights into recruitment, design, and the effectiveness of the intervention for the future long-term (12-month) PRECISE-DIET STUDY
Interventions
OTHERThe precise diet intervention
The intervention includes training and education in CGM use and reduction in overall carbohydrate intake guided by individualized flexible nutrition recommendations, with adjustments made according to postprandial blood glucose responses. Staff will guide participants in the daily carbohydrate intake with personalized adjustments to accommodate individual needs by the individuals. The primary goal is to minimize the participant's time spent above 10 mmol/l
Sponsors
Steno Diabetes Center Copenhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* T2D * Diabetes duration of ≥12 months * ≥18 years of age * HbA1c ≥58 mmol/mol * Attending the SDCC outpatient clinic * Provided voluntary signed informed consent.
Exclusion criteria
* Inability to understand the patient information. * Complications which do not permit to lowering HbA1c to \<58 mmol/mol. * Treatment with insulin. * Low daily carbohydrate intake (defined as below 25 E% or 100 g/day) prior to study inclusion. * Systematic use of corticosteroids. * Using or requiring a specialized diet (e.g., kidney diet). * Circumstances that affect HbA1c (e.g., liver disease and anaemia). * Known or suspected drug or alcohol abuse (judged by the investigator). * Pregnancy or breastfeeding or plans of pregnancy within the study period. * Participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity testing | 12 weeks after baseline | Participants will be invited to a workshop to evaluate the intervention and its components. Procedures from fidelity testing will be applied in the evaluation. These specific topics will be evaluated: * Study design o Is the design appropriate? E.g., number of visits, CGM use, dietetic feedback? * Sampling strategy o E.g., how many participated, recruitment methods, sample diversity? * Treatment receipt * "What is learned?" * Is the intervention relevant to and accepted by the participants? * Treatment enactment * What is actually used and done? * Do participants' "behavioural skills" improve? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (mmol/mol) | Measured at baseline and after 12 weeks | Assessed from blood samples |
| Time in range (TIR) | Measured at baseline and after 12 weeks | Time spent in time in range 3.9 mmol/l - 10.0 mmol/l from CGM data |
| Time above range (TAR) | Measured at baseline and after 12 weeks | Time spent in time above range 10.1-13.9 mmol/l from CGM data |
| Time below range (TBR) | Measured at baseline and after 12 weeks | Time spent in time below range \<3.9 mmol/l from from CGM data |
| Coefficient of variation (CV) | Measured at baseline and after 12 weeks | Percentage coefficient of variation in glucose differences |
| Estimated HbA1c | Measured at baseline and after 12 weeks | Estimated HbA1c (14-days average of the CGM data) |
| Body mass index (kg/m^2) | Measured at baseline and after 12 weeks | Calculated from body weight (kg) and height (m). |
| Body weight (kg) | Measured at baseline and after 12 weeks | Measured on a digital scale |
| Waist circumference (cm) | Measured at baseline and after 12 weeks | Measured using tape measure. |
| Hip circumference (cm) | Measured at baseline and after 12 weeks | Measured using tape measure |
| Systolic blood pressure (mmHg) | Measured at baseline and after 12 weeks | Measured under resting |
| Diastolic blood pressure (mmHg) | Measured at baseline and after 12 weeks | Measured under resting |
| Self-reported diabetes distress | Measured at baseline and after 12 weeks | Assessed from the Problem Areas in Diabetes Scale comprising of twenty emotional-distress questions. Each item can be rated from 0 to 5. |
| Self-reported treatment satisfaction | Measured at baseline and after 12 weeks | Assessed from the questionnaire Diabetes Treatment Satisfaction Questionnaire (DTSQ). |
| Dietary intake | Measured at baseline and after 12 weeks | Dietary intake (total energy intake and macronutrient composition based on 3-days' diet records) |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORBettina Ewers, PhD
Steno Diabetes Center Copenhagen
Outcome results
None listed