NCT05766735Recruiting
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
A Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle program called GEM. Our hypothesis is that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Feb 2023
- Start date
- 8 Aug 2023
- Primary completion date
- 31 May 2027
- Lead sponsor
- Chiara Fabris, PhD
- Diseases
- Type 2 diabetes
- NCT number
- NCT05766735
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 8 Aug 2023 to the primary completion date, 31 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medications that impede weight loss within the last 3 months, per study physicians' discretion
Other illness
- Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
- Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
- 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
- Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
- 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
- Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
- Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.
Lab values
- Any psychotropic medication that could raise blood glucose, per study physicians' opinion
- Renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b)
Other
- Currently pregnant or contemplating pregnancy within the next 14 months
- Currently breastfeeding
Who the study is looking for
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months
- Age ≥30.0 and ≤80 years
- Hemoglobin A1c = ≥6.5-≤11% (medical record value \<6 month-old is acceptable)
- Access to smartphone throughout the study
- Diabetes management visit with medical provider within 12 months of screening date
- If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Department of Family Medicine Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Virginia Center for Diabetes Technology Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.