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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06832059
• Lead Sponsor: Steno Diabetes Center Copenhagen

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

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Study Start: 2025-03
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Steno Diabetes Center Copenhagen; 🇩🇰 Herlev, Denmark