Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Type 2 Diabetes Clinical Trial

— GEM  

Official title:

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766735
• Other study ID #: 220259
• Secondary ID: R01DK129687
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: January 31, 2027

Study information

• Verified date: March 2024
• Source: University of Virginia
• Contact: Corey Rynders, MEd, PhD
• Phone: 434-422-2653
• Email: car2r[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The proposed study will compare individualized self-administered versions of RC+GEM to RC among patients recently diagnosed with type 2 diabetes. We hypothesize that, compared to RC alone, RC+GEM will be at least as effective at improving blood glucose control (A1c), and RC+GEM will do so with less reliance on diabetes medication and with greater secondary benefits such as lower risk of cardiovascular disease, more "good" cholesterol (HDL), greater weight loss, a greater sense of empowerment, and fewer diabetes-related expenses. It is further hypothesized that these benefits will be sustained over 13.5-months of follow-up with no structured maintenance program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria

1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes diagnosed within the past 12 months

2. Age =30.0 and =80 years old at time of consent

3. Hemoglobin A1c = =6.5-=9% (medical record value <6-months is acceptable)

4. Access to Smartphone throughout the study

5. Diabetes management visit with PCP within six months of screening date

Exclusion Criteria:

1. Medications that have affected participant's weight (e.g., prednisone) within the last 3 months

2. Participation in an exercise program to lose weight since last hemoglobin A1c blood test

3. Currently taking psychotropic medications that raise blood glucose (e.g., atypical antipsychotics) such as clozapine, olanzapine, risperidone, quetiapine, asenapine, arirprazole, brexpiprazole, iloperidone, lurasidone, paliperidone, and ziprasidone

4. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)

5. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)

6. Conditions that prevent doing the self-directed GEM program, such as inability to read English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression

7. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies

8. Severe vision impairment that at PI discretion would preclude ability to read the GEM manual or see the information on the CGM or activity tracker

9. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study

10. No marked renal impairment (for example eGFR < 45 mL/min/1.73 meters squared; CKD-3b)

11. Currently pregnant or contemplating pregnancy within the next 14 months

12. Currently breastfeeding

13. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Routine Care + Glycemic Excursion Minimization (RC+GEM)
In addition to receiving routine care, participants will receive GEM, a structured, self-directed, and personalized program that will allow participants with pre-diabetes to improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their blood glucose levels and variability.

Other:
• Routine Care (RC)
RC participants will meet with their primary care provider to determine the best diabetes medication and proper dose. The participant will be allowed to change medications, or use a combination of medications, that is best suited for their care during the duration of the study. The study team will not influence these decisions.

Locations

Country	Name	City	State
United States	University of Colorado Department of Family Medicine	Aurora	Colorado
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Chiara Fabris, PhD	DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c at 4.5-months of follow-up	Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 4.5-month assessment.	4.5 months
Primary	Change in Hemoglobin A1c at the 13.5-months of follow-up	Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 13.5-month assessment.	13.5 months
Primary	Change in Metformin at 4.5-months of follow-up	Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 4.5-month assessment.	4.5 months
Primary	Change in Metformin at 13.5-months of follow-up	Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 13.5-month assessment.	13.5 months