NCT05766735 Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
| NCT ID | NCT05766735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiara Fabris, PhD |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-08 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-08-08 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria 1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months 2. Age ≥30.0 and ≤80 years 3. Hemoglobin A1c = ≥6.5-≤11% (medical record value \<6 month-old is acceptable) 4. Access to smartphone throughout the study 5. Diabetes management visit with medical provider within 12 months of screening date 6. If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks Exclusion Criteria: 1. Medications that impede weight loss within the last 3 months, per study physicians' discretion 2. Any psychotropic medication that could raise blood glucose, per study physicians' opinion 3. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse) 4. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke) 5. 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 6. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies 7. 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 8. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study 9. Renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b) 10. Currently pregnant or contemplating pregnancy within the next 14 months 11. Currently breastfeeding 12. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.
Contact & Investigator
Chiara Fabris, PhD
PRINCIPAL INVESTIGATOR
University of Virginia Center for Diabetes Technology
Frequently Asked Questions
Who can join the NCT05766735 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05766735 currently recruiting?
Yes, NCT05766735 is actively recruiting participants. Contact the research team at ZMT8XG@uvahealth.org for enrollment information.
Where is the NCT05766735 trial being conducted?
This trial is being conducted at Aurora, United States, Charlottesville, United States.
Who is sponsoring the NCT05766735 clinical trial?
NCT05766735 is sponsored by Chiara Fabris, PhD. The principal investigator is Chiara Fabris, PhD at University of Virginia Center for Diabetes Technology. The trial plans to enroll 200 participants.
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