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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precise diet intervention | Experimental | The precise diet intervention for 12 weeks (n=20). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The precise diet intervention | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity testing | 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:
| 12 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (mmol/mol) | Assessed from blood samples | Measured at baseline and after 12 weeks |
| Time in range (TIR) | Time spent in time in range 3.9 mmol/l - 10.0 mmol/l from CGM data |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glucose lowering drugs | Medication status, change in doses or discontinuation of medicine | Measured at baseline and after 12 weeks |
| Personality trait assesment | Assesed fromt the BIG FIVE Inventory questionnaire (BFI-44). Comprising of 44 items. |
Inclusion Criteria:
T2D
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Ewers, PhD | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
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|
| Measured at baseline and after 12 weeks |
| Time above range (TAR) | Time spent in time above range 10.1-13.9 mmol/l from CGM data | Measured at baseline and after 12 weeks |
| Time below range (TBR) | Time spent in time below range <3.9 mmol/l from from CGM data | Measured at baseline and after 12 weeks |
| Coefficient of variation (CV) | Percentage coefficient of variation in glucose differences | Measured at baseline and after 12 weeks |
| Estimated HbA1c | Estimated HbA1c (14-days average of the CGM data) | Measured at baseline and after 12 weeks |
| Body mass index (kg/m^2) | Calculated from body weight (kg) and height (m). | Measured at baseline and after 12 weeks |
| Body weight (kg) | Measured on a digital scale | Measured at baseline and after 12 weeks |
| Waist circumference (cm) | Measured using tape measure. | Measured at baseline and after 12 weeks |
| Hip circumference (cm) | Measured using tape measure | Measured at baseline and after 12 weeks |
| Systolic blood pressure (mmHg) | Measured under resting | Measured at baseline and after 12 weeks |
| Diastolic blood pressure (mmHg) | Measured under resting | Measured at baseline and after 12 weeks |
| Self-reported diabetes distress | Assessed from the Problem Areas in Diabetes Scale comprising of twenty emotional-distress questions. Each item can be rated from 0 to 5. | Measured at baseline and after 12 weeks |
| Self-reported treatment satisfaction | Assessed from the questionnaire Diabetes Treatment Satisfaction Questionnaire (DTSQ). | Measured at baseline and after 12 weeks |
| Dietary intake | Dietary intake (total energy intake and macronutrient composition based on 3-days' diet records) | Measured at baseline and after 12 weeks |
| Baseline |
| Physical activity | Physical activity levels measured by X3 accelerometers | Measured at baseline and after 12 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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