Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

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.

Conditions

Type 2 Diabetes

Study Overview

Study Details

Study overview

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.

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Condition
Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Department of Family Medicine, Aurora, Colorado, United States, 80045

Charlottesville

University of Virginia Center for Diabetes Technology, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Medications that have affected participant's weight (e.g., prednisone) within the last 3 months
  • 2. Participation in an exercise program to lose weight since last hemoglobin A1c blood test
  • 3. Currently taking psychotropic medications that raise blood glucose (e.g., atypical antipsychotics) such as clozapine, olanzapine, risperidone, quetiapine, asenapine, arirprazole, brexpiprazole, iloperidone, lurasidone, paliperidone, and ziprasidone
  • 4. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
  • 5. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
  • 6. 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
  • 7. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
  • 8. 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
  • 9. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
  • 10. No marked renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b)
  • 11. Currently pregnant or contemplating pregnancy within the next 14 months
  • 12. Currently breastfeeding
  • 13. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Ages Eligible for Study

30 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Chiara Fabris, PhD,

Daniel J. Cox, PhD, AHPP, PRINCIPAL_INVESTIGATOR, University of Virginia Center for Diabetes Technology

Chiara Fabris, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia Center for Diabetes Technology

Tamara Oser, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2027-01-31