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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Routine Care (RC); Behavioral: Routine Care + Glycemic Excursion Minimization (RC+GEM)

Detailed Description

The proposed study will compare individualized self-administered versions of RC+GEM to RC among patients recently diagnosed with type 2 diabetes. We hypothesize that, compared to RC alone, RC+GEM will be at least as effective at improving blood glucose control (A1c), and RC+GEM will do so with less reliance on diabetes medication and with greater secondary benefits such as lower risk of cardiovascular disease, more "good" cholesterol (HDL), greater weight loss, a greater sense of empowerment, and fewer diabetes-related expenses. It is further hypothesized that these benefits will be sustained over 13.5-months of follow-up with no structured maintenance program.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corey Rynders, MEd, PhD; Phone Number: 434-422-2653; Email: car2r@uvahealth.org
• Study Contact Backup: Name: Chiara Fabris, PhD; Phone Number: 434-982-6483; Email: cf9qe@virginia.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Department of Family Medicine
      • Contact: Tamara K. Oser, MD; Phone Number: 303-724-2060; Email: tamara.oser@cuanschutz.edu
      • Contact: Britney Prince; Phone Number: 303-724-8968; Email: britney.prince@cuanschutz.edu
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia Center for Diabetes Technology
      • Principal Investigator: Chiara Fabris, PhD
      • Sub-Investigator: Anthony McCall, MD, PhD
      • Sub-Investigator: Wen Yu, PhD
      • Sub-Investigator: Mark Conaway, PhD
      • Contact: Corey Rynders, MEd, PhD; Phone Number: 434-422-2653; Email: car2r@uvahealth.org
      • Contact: Chiara Fabris, PhD; Phone Number: 434-982-6483; Email: cf9qe@virginia.edu
      • Principal Investigator: Daniel Cox, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes diagnosed within the past 12 months
2. Age ≥30.0 and ≤80 years old at time of consent
3. Hemoglobin A1c = ≥6.5-≤9% (medical record value <6-months is acceptable)
4. Access to Smartphone throughout the study
5. Diabetes management visit with PCP within six months of screening date

Exclusion 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Care (RC); Participants will be actively working with their primary care provider during the study and will attend appointments with their provider as needed. The study team will monitor their progress at the scheduled Assessment Visits. The participants should discuss any concerns they have, including side effects or cost, in order to adjust the medication regime with their primary care team. Their physician/clinician may recommend additional things, like weight loss, exercise programs and/or diabetes education programs.	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.
Experimental: Routine Care + Glucose Excursion Minimization (RC+GEM); Participants will actively work with their primary care provider and receive personalized routine care (RC). In addition, participants will receive GEM, an individualized, person-centered, empowerment program, not a behavior modification program. GEM provides individuals with personally relevant information to make choices that will help them achieve their diabetes goals. It focuses on techniques - eating low glycemic load foods, increasing moderate and vigorous exercise, and monitoring blood glucose (BG) to educate individuals about the impact of high glycemic load nutrients and vigorous exercise. The emphasis is on minimizing glucose excursions by any practical means, e.g., nutrient selection, timing and combinations of nutrient intake, time restricted eating, eating carbohydrates after protein and fat, post prandial physical activity, whatever is personally affirmed by BG feedback.	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 Names: Glucose Everyday Matters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c at 4.5-months of follow-up	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.	4.5 months
Change in Hemoglobin A1c at the 13.5-months of follow-up	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.	13.5 months
Change in Metformin at 4.5-months of follow-up	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.	4.5 months
Change in Metformin at 13.5-months of follow-up	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.	13.5 months

Collaborators and Investigators

• Sponsor: Chiara Fabris, PhD
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); DexCom, Inc.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitor (CGM); Randomized Controlled Trial (RCT); Type 2 diabetes (T2D); Blood Glucose (BG); Newly Diagnosed Type 2 Diabetes; Routine Care (RC); Routine Care + Glycemic Excursion Minimization (RC+GEM); Primary Care Provider (PCP)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 220259; R01DK129687 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No