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
Steno Diabetes Center Copenhagen
20 participants
Nov 18, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria10
- 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.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06832059