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

NCT06832059 | Recruiting

• 1 other identifier: H-24083559
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Dietary intervention; CGM; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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: * 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?

  12 weeks after baseline

Secondary Outcomes (15)

• HbA1c (mmol/mol)

  Measured at baseline and after 12 weeks

• Time in range (TIR)

  Measured at baseline and after 12 weeks

• Time above range (TAR)

  Measured at baseline and after 12 weeks

• Time below range (TBR)

  Measured at baseline and after 12 weeks

• Coefficient of variation (CV)

  Measured at baseline and after 12 weeks

Other Outcomes (3)

• Changes in glucose lowering drugs

  Measured at baseline and after 12 weeks

• Personality trait assesment

  Baseline

• Physical activity

  Measured at baseline and after 12 weeks

Study Arms (1)

Precise diet intervention

EXPERIMENTAL

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

Other: The precise diet intervention

Interventions

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

Precise diet intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2D
• Diabetes duration of ≥12 months
• ≥18 years of age
• HbA1c ≥58 mmol/mol
• Attending the SDCC outpatient clinic
• Provided voluntary signed informed consent.

You may not qualify if:

• Inability to understand the patient information.
• Complications which do not permit to lowering HbA1c to \<58 mmol/mol.
• Treatment with insulin.
• 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.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bettina Ewers, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bettina Ewers, PhD

CONTACT

0045 30912997; bettina.ewers@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition and PhD

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 18, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)