Clinical trial NCT06832059: Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial.
        -A Pilot Study
Official title: Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial.
        -A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Dietary intervention
CGM
continuous glucose monitoring
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Fidelity testing
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: HbA1c (mmol/mol)
timeFrame: Measured at baseline and after 12 weeks
measure: Time in range (TIR)
timeFrame: Measured at baseline and after 12 weeks
measure: Time above range (TAR)
timeFrame: Measured at baseline and after 12 weeks
measure: Time below range (TBR)
timeFrame: Measured at baseline and after 12 weeks
measure: Coefficient of variation (CV)
timeFrame: Measured at baseline and after 12 weeks
measure: Estimated HbA1c
timeFrame: Measured at baseline and after 12 weeks
measure: Body mass index (kg/m^2)
timeFrame: Measured at baseline and after 12 weeks
measure: Body weight (kg)
timeFrame: Measured at baseline and after 12 weeks
measure: Waist circumference (cm)
timeFrame: Measured at baseline and after 12 weeks
measure: Hip circumference (cm)
timeFrame: Measured at baseline and after 12 weeks
measure: Systolic blood pressure (mmHg)
timeFrame: Measured at baseline and after 12 weeks
measure: Diastolic blood pressure (mmHg)
timeFrame: Measured at baseline and after 12 weeks
measure: Self-reported diabetes distress
timeFrame: Measured at baseline and after 12 weeks
measure: Self-reported treatment satisfaction
timeFrame: Measured at baseline and after 12 weeks
measure: Dietary intake
timeFrame: Measured at baseline and after 12 weeks
Other outcomes:
measure: Changes in glucose lowering drugs
timeFrame: Measured at baseline and after 12 weeks
measure: Personality trait assesment
timeFrame: Baseline
measure: Physical activity
timeFrame: Measured at baseline and after 12 weeks
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
References: