Treating Early Type 2 Diabetes with Lifestyle Changes

This study is for people recently diagnosed with type 2 diabetes, aged 30 to 80, who have a smartphone. It compares two approaches: routine care (RC) with your doctor, or routine care plus a program called Glycemic Excursion Minimization (RC+GEM). RC+GEM is a personalized program that helps you understand how food and activity affect your blood sugar. Researchers want to see if RC+GEM can lower your Hemoglobin A1c (a measure of blood sugar control) as much or more than RC alone, potentially with less need for diabetes medication. The study will track these changes over 4.5 and 13.5 months. The current recruitment status is unclear.

Study design
This is a randomized controlled trial with 200 participants, split evenly between two groups. It is an interventional study, but the phase is not specified.
What's involved
Participants will either receive routine care or routine care plus a structured, self-directed lifestyle program. Remote study visits are permitted, including videoconferencing, phone, text messages, and emails.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 13.5 months after starting the study interventions.

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NCT05766735

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

Recruiting
NAAges 30–80InterventionalSupportive care
Chiara Fabris, PhD
~200 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Routine Care + Glycemic Excursion Minimization (RC+GEM)Routine Care (RC)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hemoglobin A1c at 4.5-months of follow-up
Measured over 4.5 months
+3 more outcomes measured
Type 2 Diabetes
2 sites across 2 states
Colorado1
Virginia1
  • Chiara Fabris, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia Center for Diabetes Technology
  • Daniel J. Cox, PhD, AHPP · PRINCIPAL_INVESTIGATOR · University of Virginia Center for Diabetes Technology
  • Tamara Oser, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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  • Change in Hemoglobin A1c at 4.5-months of follow-up4.5 months

    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-up13.5 months

    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-up4.5 months

    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-up13.5 months

    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.