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
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
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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?
Trial sites (1)
Facility
City
Region
Status
Steno Diabetes Center Copenhagen
Herlev
Denmark
More Steno Diabetes Center Copenhagen trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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