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

NCT ID: NCT06832059

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-18
• Study Completion Date: 2026-08-31

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Precise diet intervention

The precise diet intervention for 12 weeks (n=20).

Group Type: EXPERIMENTAL

The precise diet intervention

Intervention Type: 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

Interventions

The 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Bettina Ewers

Head of Nutrition and PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bettina Ewers, PhD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Bettina Ewers, PhD

Role: CONTACT

bettina.ewers@regionh.dk

0045 30912997

Facility Contacts

Bettina Ewers, PhD

Role: primary

bettina.ewers@regionh.dk

0045 30912997

Other Identifiers

H-24083559

Identifier Type: -

Identifier Source: org_study_id