RC+GEM Lifestyle Modification for Type 2 Diabetes
(GEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on weight-altering medications, you should be on a stable dose for about four weeks before joining. Also, certain medications that impede weight loss or raise blood glucose might be excluded, so it's best to discuss your specific medications with the study team.
Is the RC+GEM Lifestyle Modification for Type 2 Diabetes safe for humans?
Research indicates that the GEM lifestyle intervention, which is part of the RC+GEM treatment, appears to be safe for adults with type 2 diabetes. It has been shown to improve blood sugar control and quality of life without increasing risks like low blood sugar or negative changes in blood fats.12345
How is the GEM treatment for type 2 diabetes different from other treatments?
The GEM treatment is unique because it focuses on minimizing blood sugar spikes after eating, rather than just aiming for weight loss. It uses continuous glucose monitoring to help patients understand and manage their blood sugar levels, which can reduce the need for diabetes medication and improve overall quality of life.13456
What data supports the effectiveness of the treatment Glycemic Excursion Minimization (GEM) for Type 2 Diabetes?
Research shows that the Glycemic Excursion Minimization (GEM) treatment significantly improves blood sugar control (HbA1c levels) and reduces the need for diabetes medication compared to routine care. It also enhances diabetes knowledge, quality of life, and reduces diabetes-related stress without increasing dietary fat or causing low blood sugar.13456
Who Is on the Research Team?
Daniel J. Cox, PhD, AHPP
Principal Investigator
University of Virginia Center for Diabetes Technology
Chiara Fabris, PhD
Principal Investigator
University of Virginia Center for Diabetes Technology
Tamara K. Oser, MD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for adults aged 30-80 who've been diagnosed with type 2 diabetes in the last year, have an A1c level between ≥6.5-≤9%, and can use a smartphone. It's not for those with severe dietary restrictions, marked kidney issues, currently pregnant or breastfeeding women, people on certain weight-affecting or glucose-raising meds, or those with conditions that limit diet and exercise.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Routine Care (RC) or Routine Care + Glucose Excursion Minimization (RC+GEM) for diabetes management
Follow-up
Participants are monitored for changes in Metformin and Hemoglobin A1c levels
What Are the Treatments Tested in This Trial?
Interventions
- Glycemic Excursion Minimization (GEM)
- Medication Management (MM)
Glycemic Excursion Minimization (GEM) is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daniel Cox, PhD
Lead Sponsor
Chiara Fabris, PhD
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
DexCom, Inc.
Industry Sponsor
Kevin Sayer
DexCom, Inc.
Chief Executive Officer since 2015
Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University
Dr. Shelly Lane
DexCom, Inc.
Chief Medical Officer since 2023
MD from University of California, San Diego