Actively Recruiting
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Led by Chiara Fabris, PhD · Updated on 2026-04-09
200
Participants Needed
2
Research Sites
198 weeks
Total Duration
On this page
Sponsors
C
Chiara Fabris, PhD
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of type 2 diabetes within the past 24 months
- Age between 30 and 80 years
- Hemoglobin A1c between 6.5% and 11% with a test done within the last 6 months
- Access to a smartphone throughout the study
- Diabetes management visit with a medical provider within 12 months before screening
- Stable dose of weight-altering medications (e.g., GLP-1, GIP) for about four weeks if applicable
You will not qualify if you...
- Use of medications that impede weight loss within the last 3 months as decided by study physicians
- Use of psychotropic medications that may raise blood glucose based on study physicians' opinion
- Severe mental illness such as manic depressive illness or severe depression
- Active substance abuse
- Conditions preventing increased physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
- Inability to do the self-directed GEM program due to language or mental health issues
- Severe diet restrictions like gastroparesis, ulcers, or food allergies
- Severe vision impairment that limits reading study materials or devices
- Current cancer treatment that precludes participation
- Renal impairment with eGFR less than 45 mL/min/1.73 m2
- Currently pregnant or planning pregnancy within 14 months
- Currently breastfeeding
- Any condition that the principal investigator believes would interfere with safe and effective study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Colorado Department of Family Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
J
Jacqueline Rodriguez
CONTACT
M
Matthew Moncrief
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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