Clinical trial NCT05766735: Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Official title: Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Routine Care (RC)
Routine Care + Glycemic Excursion Minimization (RC+GEM)
Continuous Glucose Monitor (CGM)
Randomized Controlled Trial (RCT)
Blood Glucose (BG)
Newly Diagnosed Type 2 Diabetes
Type 2 diabetes (T2D)
Primary Care Provider (PCP)
Remote Study Visits
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: DexCom, Inc.
First posted: 2023-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to individualized routine care (RC) or to individualized RC in addition to post-nutrient glucose excursion minimization (RC+GEM). A Randomized Controlled Trial (RCT) design will be used to assign participants to treatment groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria

1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months
2. Age ≥30.0 and ≤80 years
3. Hemoglobin A1c = ≥6.5-≤11% (medical record value \<6 month-old is acceptable)
4. Access to smartphone throughout the study
5. Diabetes management visit with medical provider within 12 months of screening date
6. If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks

Exclusion Criteria:

1. Medications that impede weight loss within the last 3 months, per study physicians' discretion
2. Any psychotropic medication that could raise blood glucose, per study physicians' opinion
3. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
4. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
5. 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
6. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
7. 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
8. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
9. Renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b)
10. Currently pregnant or contemplating pregnancy within the next 14 months
11. Currently breastfeeding
12. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Primary outcomes:
measure: Change in Hemoglobin A1c at 4.5-months of follow-up
timeFrame: 4.5 months
measure: Change in Hemoglobin A1c at the 13.5-months of follow-up
timeFrame: 13.5 months
measure: Change in Metformin at 4.5-months of follow-up
timeFrame: 4.5 months
measure: Change in Metformin at 13.5-months of follow-up
timeFrame: 13.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Department of Family Medicine
state: Colorado
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia Center for Diabetes Technology
name: Chiara Fabris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Center for Diabetes Technology
name: Daniel J. Cox, PhD, AHPP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Tamara Oser, MD
role: PRINCIPAL_INVESTIGATOR
References: