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RC+GEM Lifestyle Modification for Type 2 Diabetes (GEM Trial)
N/A
Recruiting
Led By Daniel J. Cox, PhD, AHPP
Research Sponsored by Daniel Cox, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis, based on investigator assessment, of type 2 diabetes diagnosed within the past 12 months
Age ≥30.0 and ≤80 years old at time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13.5 months
Awards & highlights
GEM Trial Summary
This trial tests if self-managed diabetes treatment can be more effective and cost less than traditional meds for newly-diagnosed Type 2 Diabetes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on lifestyle changes rather than medication, side effects may include discomfort from wearing a continuous glucose monitor and potential stress from adapting to new diet and exercise routines.
GEM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with type 2 diabetes in the last year.
Select...
I am between 30 and 80 years old.
GEM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13.5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Hemoglobin A1c at 4.5-months of follow-up
Change in Hemoglobin A1c at the 13.5-months of follow-up
Change in Metformin at 13.5-months of follow-up
+1 moreGEM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Routine Care + Glucose Excursion Minimization (RC+GEM)Experimental Treatment1 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 Control1 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.
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Who is running the clinical trial?
Daniel Cox, PhDLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,392 Total Patients Enrolled
Chiara Fabris, PhDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have severe health issues that stop me from being more active.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.You have been participating in a weight loss exercise program since your last hemoglobin A1c blood test.Your average blood sugar level is between 6.5% and 9% based on your recent medical records.Criterion: You are unable to participate in the self-directed GEM program if you cannot read English, have mental health conditions that make it hard to engage in treatment, like active substance abuse or severe depression.I am between 30 and 80 years old.You have severe stomach problems that make it hard for you to eat, or you have food allergies.My kidney function is not severely impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Routine Care (RC)
- Group 2: Routine Care + Glucose Excursion Minimization (RC+GEM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for this trial exclusively below 35 years?
"This clinical trial requires applicants to be aged between 18 and 80. Moreover, there are 200 studies available for minors while 1122 are dedicated to seniors."
Answered by AI
What stipulations must be met in order to participate in this clinical experiment?
"To be eligible for inclusion in this research trial, potential participants should have type 2 diabetes and must fall between 18-80 years old. 200 individuals are required to fulfill the requirements of the study."
Answered by AI
Are there any openings for new enrollees in this investigation?
"Per information provided on clinicaltrials.gov, the recruitment process for this trial is currently inactive. It was initially established on March 20th of 2023 and last updated on March 1st of that same year. On a broader level however, 1464 other trials are still recruiting patients at present time."
Answered by AI
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