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

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.

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.

Remote study visits are permitted. Clinic visit and remote visits may include videoconferencing, phone, text messages and emails.

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]
• Change in Hemoglobin A1c at the 13.5-months of follow-up [Time frame: 13.5 months]
• Change in Metformin at 4.5-months of follow-up [Time frame: 4.5 months]
• Change in Metformin at 13.5-months of follow-up [Time frame: 13.5 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• University of Colorado Department of Family Medicine — Aurora
• University of Virginia Center for Diabetes Technology — Charlottesville

Identifiers

NCT: NCT05766735 · 220259 · R01DK129687

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗