Precision nutrition versus standard dietary care using continuous glucose monitoring for type 2 diabetes
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
This 12-week pilot will try whether using continuous glucose monitors plus a tailored precision diet helps adults with type 2 diabetes lower high blood sugars compared with standard diet advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT06832059 on ClinicalTrials.gov |
What this trial studies
This 12-week pilot compares a precision, individualized dietary intervention guided by continuous glucose monitoring (CGM) with standard dietary care in adults with type 2 diabetes. Participants are adults with T2D of at least 12 months' duration, HbA1c ≥58 mmol/mol, not treated with insulin, and recruited from the Steno Diabetes Center Copenhagen outpatient clinic. The intervention uses CGM data to tailor carbohydrate amount and meal composition to reduce postprandial glucose excursions, while the control group receives usual dietary advice; feasibility, recruitment, and short-term glycemic responses will be measured. Results will inform the design and potential effectiveness of a future 12-month PRECISE-DIET study.
Who should consider this trial
Good fit: Adults (≥18) with type 2 diabetes for at least 12 months, HbA1c ≥58 mmol/mol, not using insulin, attending the Steno Diabetes Center Copenhagen outpatient clinic, and able to give informed consent.
Not a fit: People on insulin, those already on very low-carbohydrate or other specialized diets, pregnant or breastfeeding individuals, or those with conditions that affect HbA1c are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could help people with type 2 diabetes reduce post-meal glucose spikes and lower HbA1c by tailoring meals based on CGM data.
How similar studies have performed: Previous studies show CGM can improve glycemic control in type 2 diabetes, but combining CGM-guided care with individualized dietary changes is relatively novel and has limited trial evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Herlev
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Bettina Ewers, PhD — Steno Diabetes Center Copenhagen
- Study coordinator: Bettina Ewers, PhD
- Email: bettina.ewers@regionh.dk
- Phone: 0045 30912997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.