What this study is
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.
What's being tested
- Routine Care + Glycemic Excursion Minimization (RC+GEM)
Intervention · BEHAVIORAL
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.
- Routine Care (RC)
Intervention · OTHER
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.
Study details
- Sponsor
- Chiara Fabris, PhD
- Conditions
- Type 2 Diabetes
- Enrolling
- 200 people
- Starts
- 2023-08-08
- Est. completion
- 2027-05-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 30 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Colorado Department of Family Medicine
Aurora, Colorado, United States
- Tamara K. Oser, MD · Contact303-724-2060tamara.oser@cuanschutz.edu
- Britney Prince · Contact303-724-8968britney.prince@cuanschutz.edu
RecruitingUniversity of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
- Chiara Fabris, PhD · Contact434-982-6483cf9qe@virginia.edu
- Jacqueline Rodriguez · Contact434-422-2653ZMT8XG@uvahealth.org
- Chiara Fabris, PhD · Principal investigator
- Anthony McCall, MD, PhD · Sub-investigator
- Wen Yu, PhD · Sub-investigator
- Mark Conaway, PhD · Sub-investigator
- Daniel Cox, PhD · Principal investigator
- Catherine Varney, DO · Sub-investigator
Recruiting
Study team
Sponsor
Chiara Fabris, PhD
Study ID 220259
Principal investigator
Chiara Fabris, PhD
University of Virginia Center for Diabetes Technology
Principal investigator
Daniel J. Cox, PhD, AHPP
University of Virginia Center for Diabetes Technology
Principal investigator
Tamara Oser, MD
University of Colorado, Denver
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.