NCT05766735 · Chiara Fabris, PhD
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
(GEM)
What this study is about
A randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Routine Care + Glycemic Excursion Minimization (RC+GEM)
In addition to receiving routine care, participants will receive GEM, a structured, self-directed, and personalized program that will allow participants with pre-diabetes to improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their blood glucose levels and variability.
OTHER
Routine Care (RC)
RC participants will meet with their primary care provider to determine the best diabetes medication and proper dose. The participant will be allowed to change medications, or use a combination of medications, that is best suited for their care during the duration of the study. The study team will not influence these decisions.
Primary outcome measures
Change in Hemoglobin A1c at 4.5-months of follow-up
Time frame: 4.5 months
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 4.5-month assessment.
Change in Hemoglobin A1c at the 13.5-months of follow-up
Time frame: 13.5 months
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 13.5-month assessment.
Change in Metformin at 4.5-months of follow-up
Time frame: 4.5 months
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 4.5-month assessment.
Change in Metformin at 13.5-months of follow-up
Time frame: 13.5 months
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 13.5-month assessment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Medications that impede weight loss within the last 3 months, per study physicians' discretion
- Any psychotropic medication that could raise blood glucose, per study physicians' opinion
- 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
- Renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b)
- Currently pregnant or contemplating pregnancy within the next 14 months
- Currently breastfeeding
- Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.
Where
- Aurora, Colorado
- Charlottesville, Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations