RecruitingNot ApplicableNCT05766735

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

Sponsor

Chiara Fabris, PhD

Enrollment

200 participants

Start Date

Aug 8, 2023

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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.

Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new lifestyle approach to managing early type 2 diabetes by focusing on reducing blood sugar spikes after meals (rather than the traditional focus on overall calorie restriction). Participants will use a smartwatch and app to track their sugar levels and activity. **You may be eligible if...** - You have been diagnosed with type 2 diabetes within the past 24 months - You are between 30 and 80 years old - Your HbA1c (a measure of blood sugar control) is between 6.5% and 11% - You own a smartphone and can use it throughout the study - You have seen a doctor for diabetes management within the past year **You may NOT be eligible if...** - You are taking medications that prevent weight loss - You take certain psychiatric medications - You are unable to use a smartphone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALRoutine 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.

OTHERRoutine 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.