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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine Care + Glycemic Excursion Minimization (RC+GEM)
Routine Care (RC)
Sponsored by
Chiara Fabris, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Routine Care (RC), Routine Care + Glycemic Excursion Minimization (RC+GEM), Continuous Glucose Monitor (CGM), Randomized Controlled Trial (RCT), Blood Glucose (BG), Newly Diagnosed Type 2 Diabetes, Type 2 diabetes (T2D), Primary Care Provider (PCP)

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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 Hemoglobin A1c = ≥6.5-≤9% (medical record value <6-months is acceptable) Access to Smartphone throughout the study Diabetes management visit with PCP within six months of screening date Exclusion Criteria: Medications that have affected participant's weight (e.g., prednisone) within the last 3 months Participation in an exercise program to lose weight since last hemoglobin A1c blood test 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 Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse) Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke) 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 Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies 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 Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study No marked renal impairment (for example eGFR < 45 mL/min/1.73 meters squared; CKD-3b) Currently pregnant or contemplating pregnancy within the next 14 months Currently breastfeeding Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Sites / Locations

  • University of Colorado Department of Family Medicine
  • University of Virginia Center for Diabetes TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine Care (RC)

Routine Care + Glucose Excursion Minimization (RC+GEM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
September 26, 2023
Sponsor
Chiara Fabris, PhD
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05766735
Brief Title
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Acronym
GEM
Official Title
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chiara Fabris, PhD
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Routine Care (RC), Routine Care + Glycemic Excursion Minimization (RC+GEM), Continuous Glucose Monitor (CGM), Randomized Controlled Trial (RCT), Blood Glucose (BG), Newly Diagnosed Type 2 Diabetes, Type 2 diabetes (T2D), Primary Care Provider (PCP)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to individualized routine care (RC) or to individualized RC in addition to post-nutrient glucose excursion minimization (RC+GEM). A Randomized Controlled Trial (RCT) design will be used to assign participants to treatment groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine Care (RC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Routine Care + Glucose Excursion Minimization (RC+GEM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine Care + Glycemic Excursion Minimization (RC+GEM)
Other Intervention Name(s)
Glucose Everyday Matters
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Care (RC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c at 4.5-months of follow-up
Description
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.
Time Frame
4.5 months
Title
Change in Hemoglobin A1c at the 13.5-months of follow-up
Description
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.
Time Frame
13.5 months
Title
Change in Metformin at 4.5-months of follow-up
Description
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.
Time Frame
4.5 months
Title
Change in Metformin at 13.5-months of follow-up
Description
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.
Time Frame
13.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Hemoglobin A1c = ≥6.5-≤9% (medical record value <6-months is acceptable) Access to Smartphone throughout the study Diabetes management visit with PCP within six months of screening date Exclusion Criteria: Medications that have affected participant's weight (e.g., prednisone) within the last 3 months Participation in an exercise program to lose weight since last hemoglobin A1c blood test 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 Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse) Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke) 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 Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies 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 Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study No marked renal impairment (for example eGFR < 45 mL/min/1.73 meters squared; CKD-3b) Currently pregnant or contemplating pregnancy within the next 14 months Currently breastfeeding Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corey Rynders, MEd, PhD
Phone
434-422-2653
Email
car2r@uvahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J. Cox, PhD, AHPP
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chiara Fabris, PhD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamara Oser, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Department of Family Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara K. Oser, MD
Phone
303-724-2060
Email
tamara.oser@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Britney Prince
Phone
303-724-8968
Email
britney.prince@cuanschutz.edu
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel J. Cox, PhD, AHPP
Phone
434-982-0602
Email
djc4f@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Corey Rynders, MEd, PhD
Phone
434-422-2653
Email
car2r@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Chiara Fabris, PhD
First Name & Middle Initial & Last Name & Degree
Anthony McCall, MD, PhD
First Name & Middle Initial & Last Name & Degree
Wen Yu, PhD
First Name & Middle Initial & Last Name & Degree
Mark Conaway, PhD

12. IPD Sharing Statement

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

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