Type 2 Diabetes
Conditions
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
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.
Interventions
BEHAVIORALRoutine 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.
OTHERRoutine 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.
Sponsors
Chiara Fabris, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
DexCom, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c at 4.5-months of follow-up | 4.5 months | 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. |
| Change in Hemoglobin A1c at the 13.5-months of follow-up | 13.5 months | 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. |
| Change in Metformin at 4.5-months of follow-up | 4.5 months | 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. |
| Change in Metformin at 13.5-months of follow-up | 13.5 months | 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. |
Countries
United States
Contacts
CONTACTJacqueline Rodriguez
CONTACTMatthew Moncrief
PRINCIPAL_INVESTIGATORChiara Fabris, PhD
University of Virginia Center for Diabetes Technology
PRINCIPAL_INVESTIGATORDaniel J. Cox, PhD, AHPP
University of Virginia Center for Diabetes Technology
PRINCIPAL_INVESTIGATORTamara Oser, MD
University of Colorado, Denver
Outcome results
None listed