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Recruiting 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

Trial Parameters

Condition Type 2 Diabetes
Sponsor Steno Diabetes Center Copenhagen
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-18
Completion 2026-08-31
Interventions
The precise diet intervention

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

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.

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