Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Sponsor: Chiara Fabris, PhD
Trial Details
| Condition | Type 2 Diabetes |
| Intervention | Routine Care + Glycemic Excursion Minimization (RC+GEM); Routine Care (RC) |
| Phase | NA |
| Status | Recruiting |
| Participants | 200 |
| Est. Completion | 31 May 2027 |
| Last Updated | 9 Apr 2026 |
Primary Outcome
Change in Hemoglobin A1c at 4.5-months of follow-up; Change in Hemoglobin A1c at the 13.5-months of follow-up; Change in Metformin at 4.5-months of follow-up; Change in Metformin at 13.5-months of follow-up
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria 1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months 2. Age ≥30.0 and ≤80 years 3. Hemoglobin A1c = ≥6.5-≤11% (medical record value \<6 month-old is acceptable) 4. Access to smartphone throughout the study 5. Diabetes management visit with medical provider within 12 months of screening date 6. If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks Exclusion Criteria: 1. Medications that impede weight loss within the last 3 months, per study physicians' discretion 2. Any psychotropic medication that could raise blood glucose, per study physicians' opinion 3. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse) 4. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke) 5. Conditions that prevent doing the self-directed GEM program, such as inability to read English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression 6. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies 7. Severe vision impairment that at PI discretion would preclude ability to read the GEM manual or see the information on the CGM or activity tracker 8. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study 9. Renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b) 10. Currently pregnant or contemplating pregnancy within the next 14 months 11. Currently breastfeeding 12. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.
Trial Sites
Countries
This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service