RECRUITING

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

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Conditions

Type 2 DiabetesRoutine Care (RC)Routine Care + Glycemic Excursion Minimization (RC+GEM)Continuous Glucose Monitor (CGM)Randomized Controlled Trial (RCT)Blood Glucose (BG)Newly Diagnosed Type 2 DiabetesType 2 diabetes (T2D)Primary Care Provider (PCP)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-08
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05766735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Medications that have affected participant's weight (e.g., prednisone) within the last 3 months
  2. 2. Participation in an exercise program to lose weight since last hemoglobin A1c blood test
  3. 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. 4. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
  5. 5. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
  6. 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. 7. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
  8. 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. 9. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
  10. 10. No marked renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b)
  11. 11. Currently pregnant or contemplating pregnancy within the next 14 months
  12. 12. Currently breastfeeding
  13. 13. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Contacts and Locations

Study Contact

Corey Rynders, MEd, PhD
CONTACT
434-422-2653
car2r@uvahealth.org
Chiara Fabris, PhD
CONTACT
434-982-6483
cf9qe@virginia.edu

Principal Investigator

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 Oser, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado Department of Family Medicine
Aurora, Colorado, 80045
United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Chiara Fabris, PhD

  • 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 Oser, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2023-08-08
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • 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)

Additional Relevant MeSH Terms

  • Type 2 Diabetes