Personalized nutrition guided by continuous glucose monitors for people with type 2 diabetes
Personalized Nutrition Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
This study tests whether using continuous glucose monitor feedback to personalize medical nutrition therapy helps adults with type 2 diabetes (HbA1c 6.8–8.5%) improve blood sugar control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06784375 on ClinicalTrials.gov |
What this trial studies
Adults with type 2 diabetes and HbA1c 6.8–8.5% who are not treated with insulin or certain diabetes drugs are randomized to one of four groups combining unblinded or blinded continuous glucose monitoring (CGM) with or without personalized medical nutrition therapy. Participants in the personalized nutrition arms receive tailored dietary advice based on their CGM glucose patterns, while control arms use CGM without receiving nutrition counseling. The trial compares changes in glycemic measures such as HbA1c and CGM-derived time-in-range and postprandial glucose over the intervention period. The study is conducted at the University of Minnesota and requires in-person visits for enrollment and follow-up.
Who should consider this trial
Good fit: Adults (≥18) with type 2 diabetes, HbA1c between 6.8% and 8.5%, BMI ≥25 kg/m2 (or ≥23 kg/m2 for Asian participants), eGFR ≥60 ml/min/1.73 m2, not using insulin, sulfonylureas, or meglitinides, and willing to attend visits at the University of Minnesota.
Not a fit: People using insulin or sulfonylureas, with type 1 diabetes, significant kidney impairment, low BMI, recent weight change, pregnancy, breastfeeding, or anemia are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, personalized CGM-guided nutrition could improve glucose control and reduce high blood sugar spikes without adding medication.
How similar studies have performed: Previous smaller trials and pilot studies have shown that CGM-informed dietary feedback can reduce postprandial glucose excursions and improve time-in-range, but large definitive trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at least 18 years of age * previous diagnosis of T2DM * HbA1c of 6.8-8.5% Exclusion Criteria: * type 1 diabetes mellitus * treatment with insulin, sulfonylurea, or meglitinide * use of nondiabetic medications that affect blood glucose control (such as corticosteroids) * BMI \<25 kg/m2 or \<23 kg/m2 for participants who self-identify as Asian * weight change \>5 pounds in the 3 months prior to study enrollment * estimated glomerular filtration rate \<60 ml/minute/1.73 m2 * pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Anne Bantle — University of Minnesota
- Study coordinator: Anne Bantle
- Email: bant0015@umn.edu
- Phone: 612-625-8673
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.