Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
GEM
2 other identifiers
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Aug 2023
Longer than P75 for not_applicable type-2-diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
April 9, 2026
May 1, 2025
3.8 years
February 10, 2023
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Routine Care (RC)
ACTIVE COMPARATORParticipants 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.
Routine Care + Glucose Excursion Minimization (RC+GEM)
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiara Fabris, PhDlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- DexCom, Inc.collaborator
Study Sites (2)
University of Colorado Department of Family Medicine
Aurora, Colorado, 80045, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2023
First Posted
March 13, 2023
Study Start
August 8, 2023
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
April 9, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available after the publication of the manuscript.
- Access Criteria
- The Data Sharing Agreements will be formulated by the study team
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.