RC+GEM Lifestyle Modification for Type 2 Diabetes

(GEM Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Daniel J. Cox, PhD, AHPP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

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. ^{1 2 3 4 5}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Glycemic Excursion Minimization (GEM) (Behavioral)
• Medication Management (MM) (Other)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Virginia Center for Diabetes Technology Charlottesville, VA

University of Colorado Department of Family Medicine Aurora, CO

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial. [2021] This study aimed to compare conventional medication management of type 2 diabetes (T2D) to medication management in conjunction with a lifestyle intervention using continuous glucose monitoring to minimize glucose excursions. Thirty adults (63% female; mean age, 53.3 years) who were diagnosed with T2D for less than 11 years (mean, 5.6 years), had glycated A1c (HbA1c) ≥ 7.0% (51 mmol/mol) (mean 8.8%, [73 mmol/mol]), and were not using insulin, were randomly assigned in a 1:2 ratio to routine care (RC) or 4 group sessions of glycemic excursion minimization plus real-time CGM (GEMCGM). Assessments at baseline and 5 months included a physical exam, metabolic and lipid panels, a review of diabetes medications, and psychological questionnaires. For the week following assessments, participants wore a blinded activity monitor and completed 3 days of 24-hour dietary recall. A subgroup also wore a blinded CGM. GEMCGM participants significantly improved HbA1c (from 8.9% to 7.6% [74-60 mmol/mol] compared with 8.8% to 8.7% [73-72 mmol/mol] for RC (P = .03). Additionally, GEMCGM reduced the need for diabetes medication (P = .01), reduced carbohydrate consumption (P = .009), and improved diabetes knowledge (P = .001), quality of life (P = .01) and diabetes distress (P = .02), and trended to more empowerment (P = .05) without increasing dietary fat, lipids, or hypoglycemia. Confirming our prior research, GEMCGM appears to be a safe, effective lifestyle intervention option for adults with suboptimally controlled T2D who do not take insulin.

2. England pubmed.ncbi.nlm.nih.gov

Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial. [2021] This study of adults with type 2 diabetes employed a non-inferiority hypothesis to investigate whether an innovative lifestyle focused on minimizing postnutrient blood glucose (BG) excursions (glycemic excursion minimization (GEM)) would be equivalent or superior to conventional weight loss (WL) therapy in regard to reducing HbA1c, and superior to WL when investigating physical, behavioral and psychological secondary outcomes. The impact of BG feedback on GEM efficacy was also investigated.

3. Ireland pubmed.ncbi.nlm.nih.gov

Glycemic load, exercise, and monitoring blood glucose (GEM): A paradigm shift in the treatment of type 2 diabetes mellitus. [2018] This preliminary RCT investigated whether an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activities guided by systematic self-monitoring of blood glucose (GEM) could improve metabolic control of adults with type 2 diabetes mellitus, without compromising other physiological parameters.

4. England 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. [2021] We previously reported the physical, psychological and behavioral 3-month post-treatment results of a randomized controlled trial comparing glycemic excursion minimization (GEM) versus conventional weight loss (WL) therapy in the management of type 2 diabetes (T2D). GEM is a paradigm shift in the lifestyle management of T2D that focuses on reducing postnutrient glucose excursions, rather than reducing weight. We now present the 13-month follow-up results.

5. Canada 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. [2022] Type 2 diabetes (T2D) is a growing epidemic in the United States, and metabolic control has not been improved over the last 10 years. Glycemic excursion minimization (GEM) is an alternative lifestyle treatment option focused on reducing postnutrient glucose excursions rather than reducing weight. GEM has been proven to be superior to routine care when delivered face to face, and equivalent or superior to conventional weight loss therapy, but it has not been evaluated among patients newly diagnosed with T2D or in a self-administered format.

6. United States pubmed.ncbi.nlm.nih.gov

Exenatide improves glycemic variability assessed by continuous glucose monitoring in subjects with type 2 diabetes. [2022] Daily glycemic fluctuation leads to development of long-term complications. The aim of our pilot study was to determine if exenatide reduces glycemic variability, assessed with a continuous glucose monitoring (CGM) system, compared with glimepiride.