200 Participants Needed

RC+GEM Lifestyle Modification for Type 2 Diabetes

(GEM Trial)

Recruiting at 1 trial location
MM
CR
CF
JR
MM
Overseen ByMatthew Moncrief
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

DJ

Daniel J. Cox, PhD, AHPP

Principal Investigator

University of Virginia Center for Diabetes Technology

CF

Chiara Fabris, PhD

Principal Investigator

University of Virginia Center for Diabetes Technology

TO

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

I have seen my primary care doctor for diabetes within the last 6 months.
I was diagnosed with type 2 diabetes in the last year.
Your average blood sugar level is between 6.5% and 9% based on your recent medical records.
See 2 more

Exclusion Criteria

You have severe vision problems that could make it hard for you to read the study materials or see the information on the devices used in the study.
I haven't taken medications like prednisone that affect my weight in the last 3 months.
I am currently taking medication for mental health that may increase my blood sugar.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Routine Care (RC) or Routine Care + Glucose Excursion Minimization (RC+GEM) for diabetes management

13.5 months

Follow-up

Participants are monitored for changes in Metformin and Hemoglobin A1c levels

13.5 months

What Are the Treatments Tested in This Trial?

Interventions

  • Glycemic Excursion Minimization (GEM)
  • Medication Management (MM)
Trial Overview The study compares Routine Care (RC) to RC plus a new lifestyle program called Glycemic Excursion Minimization (GEM), which includes continuous glucose monitoring. The goal is to see if GEM helps lower blood sugar levels more effectively than standard care alone without needing as much medication.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Routine Care + Glucose Excursion Minimization (RC+GEM)Experimental Treatment1 Intervention
Group II: Routine Care (RC)Active Control1 Intervention

Glycemic Excursion Minimization (GEM) is already approved in United States for the following indications:

🇺🇸
Approved in United States as GEM for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daniel Cox, PhD

Lead Sponsor

Trials
1
Recruited
200+

Chiara Fabris, PhD

Lead Sponsor

Trials
1
Recruited
200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

DexCom, Inc.

Industry Sponsor

Trials
151
Recruited
35,700+
Kevin Sayer profile image

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 profile image

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

A lifestyle intervention combined with continuous glucose monitoring (GEMCGM) significantly improved HbA1c levels in adults with type 2 diabetes, reducing it from 8.9% to 7.6%, compared to a smaller change in the routine care group.
Participants in the GEMCGM group also experienced a reduction in diabetes medication needs, improved dietary habits, and enhanced quality of life, all without increasing dietary fat or risk of hypoglycemia.
Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial.Cox, DJ., Banton, T., Moncrief, M., et al.[2021]
The glycemic excursion minimization (GEM) approach significantly reduced HbA1c levels and improved various health metrics compared to conventional weight loss therapy in a study of 178 adults with type 2 diabetes.
Participants in the GEM program also experienced better psychological outcomes, such as improved diabetes empowerment and reduced depressive symptoms, without any negative side effects, making it a promising alternative to traditional weight loss methods.
Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial.Cox, DJ., Banton, T., Moncrief, M., et al.[2021]
The GEM lifestyle modification program significantly improved HbA1c levels in adults with type 2 diabetes, reducing it from 8.4% to 7.4%, compared to no change in the routine care group over 6 months.
Participants in the GEM program also experienced improvements in psychological functioning, indicating that the intervention not only helps with blood glucose control but also supports mental well-being without negatively affecting other health parameters.
Glycemic load, exercise, and monitoring blood glucose (GEM): A paradigm shift in the treatment of type 2 diabetes mellitus.Cox, DJ., Taylor, AG., Singh, H., et al.[2018]

Citations

Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial. [2021]
Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial. [2021]
Glycemic load, exercise, and monitoring blood glucose (GEM): A paradigm shift in the treatment of type 2 diabetes mellitus. [2018]
Long-term follow-up of a randomized clinical trial comparing glycemic excursion minimization (GEM) to weight loss (WL) in the management of type 2 diabetes. [2021]
An Innovative, Paradigm-Shifting Lifestyle Intervention to Reduce Glucose Excursions With the Use of Continuous Glucose Monitoring to Educate, Motivate, and Activate Adults With Newly Diagnosed Type 2 Diabetes: Pilot Feasibility Study. [2022]
Exenatide improves glycemic variability assessed by continuous glucose monitoring in subjects with type 2 diabetes. [2022]
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