RC+GEM Lifestyle Modification for Type 2 Diabetes

(GEM Trial)

Recruiting at 1 trial location

Overseen By Matthew Moncrief

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Daniel Cox, PhD

Must not be taking: Psychotropics, Weight loss blockers

Disqualifiers: Severe mental disease, Cardiovascular disease, Renal impairment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 13.5 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing type 2 diabetes, aiming to reduce medication needs and lower costs. Participants will receive either routine care or a combination of routine care and a personalized program called Glycemic Excursion Minimization (GEM). GEM includes continuous glucose monitoring and lifestyle changes to help stabilize blood sugar levels. The goal is to determine if GEM can better improve blood sugar control and other health factors like weight and heart health. Individuals diagnosed with type 2 diabetes in the last two years, who have access to a smartphone, and can manage lifestyle changes might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore innovative diabetes management strategies.

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.

What prior data suggests that the RC+GEM program is safe for individuals with type 2 diabetes?

Research has shown that Glycemic Excursion Minimization (GEM) is generally safe for people with type 2 diabetes. One study found that individuals using GEM achieved better blood sugar levels without serious side effects. Specifically, their hemoglobin A1c, which measures long-term blood sugar, decreased from 8.9% to 7.6%, marking a significant improvement.

Another study demonstrated that GEM reduced A1c by an average of 1.8%. Participants also reported feeling less stressed and depressed about managing their diabetes. These findings suggest that GEM not only helps control blood sugar but also enhances overall well-being safely. No major safety issues emerged in these studies, indicating that GEM is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RC+GEM Lifestyle Modification approach for treating Type 2 Diabetes because it offers a personalized and empowering method for managing the disease. Unlike standard treatments that primarily focus on medication management, RC+GEM emphasizes minimizing glucose excursions through personalized lifestyle changes. This method encourages patients to make informed choices about their diet and exercise, integrating techniques like eating low glycemic foods, engaging in regular physical activity, and using glucose monitoring feedback. These strategies aim to help individuals achieve better blood sugar control by tailoring lifestyle modifications to their unique needs and responses. This patient-centered approach could lead to more sustainable and effective diabetes management compared to traditional methods.

What evidence suggests that the RC+GEM program could be effective for type 2 diabetes?

Research has shown that the Glycemic Excursion Minimization (GEM) program, which participants in this trial may receive, can effectively manage type 2 diabetes. In one study, participants using GEM experienced a significant drop in average blood sugar levels, from 8.9% to 7.6%, compared to a small change in those receiving routine care. Another study found that 67% of participants in the GEM program achieved diabetes remission, with blood sugar levels remaining below diabetes thresholds without medication. GEM has also outperformed traditional weight loss programs in improving blood sugar control and reducing heart disease risks. This suggests that GEM could reduce the need for diabetes medications while enhancing overall health. ^{1 2 4 6 7}

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

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.

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.

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?

Group I: Routine Care + Glucose Excursion Minimization (RC+GEM) Experimental Treatment 1 Intervention

Participants 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.

Group II: Routine Care (RC) Active Control 1 Intervention

Participants 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.

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

Approved in United States as GEM for:

• Type 2 Diabetes Management
• Reduction of Postprandial Glucose Excursions

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

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

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a pilot study involving 17 adults recently diagnosed with type 2 diabetes, a self-administered glycemic excursion minimization (GEM) program combined with continuous glucose monitoring (CGM) led to 67% of participants achieving diabetes remission (HbA1c levels <6.5%) after 3 months, with a significant average reduction in HbA1c of -1.8%.

Participants reported reduced consumption of high-glycemic-load carbohydrates, lower diabetes distress, and depressive symptoms, indicating that GEM with CGM feedback can effectively improve metabolic control and empower patients without focusing primarily on weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Oser, TK., Cucuzzella, M., Stasinopoulos, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a 13-month follow-up of a study involving 172 participants with type 2 diabetes, the glycemic excursion minimization (GEM) approach showed sustained benefits in HbA1c levels and various psychological and behavioral parameters, while conventional weight loss (WL) therapy primarily maintained improvements in body mass index (BMI).

GEM participants experienced significant reductions in carbohydrate intake, increased diabetes knowledge and empowerment, and lower diabetes distress, indicating that this method may offer a more comprehensive management strategy for type 2 diabetes compared to traditional weight loss approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Cox, DJ., Oser, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a pilot study involving 12 subjects with type 2 diabetes, exenatide significantly reduced glycemic variability, as measured by continuous glucose monitoring, compared to glimepiride after 16 weeks of treatment.

Both treatments lowered fasting glucose and glycated hemoglobin levels, but only exenatide showed a significant improvement in overall glucose stability, suggesting it may offer additional benefits for glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide improves glycemic variability assessed by continuous glucose monitoring in subjects with type 2 diabetes. Irace, C., Fiorentino, R., Carallo, C., et al.[2022]

Citations

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Glycemic Excursion Minimization in Type 2 Patients

GEM participants significantly improved diabetes empowerment, diabetes distress, depressive symptoms, steps/day, and active hours and reduced calories/day. Key ...