Reducing blood sugar spikes in early type 2 diabetes through lifestyle changes
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
NA · University of Virginia · NCT05766735
This study is testing if a program that includes tracking blood sugar and personalized lifestyle changes can help people with newly diagnosed type 2 diabetes manage their condition better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05766735 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two approaches for managing newly diagnosed type 2 diabetes: standard routine care and a program that includes continuous glucose monitoring along with personalized lifestyle modifications. Participants will be randomly assigned to either routine care or the enhanced program, which aims to improve blood glucose control while reducing the need for diabetes medications. The study will assess the effectiveness of these interventions over a 13.5-month follow-up period, focusing on various health outcomes including hemoglobin A1c levels, cardiovascular risk, and overall diabetes management costs. Remote visits will be utilized to facilitate participant engagement and monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 80 who have been diagnosed with type 2 diabetes within the last 24 months and have a hemoglobin A1c level between 6.5% and 11%.
Not a fit: Patients with severe mental health conditions, significant cardiovascular disease, or those on certain medications that affect weight loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better blood sugar control and reduced reliance on medications for patients with early type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring and lifestyle modifications for diabetes management, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado Department of Family Medicine — Aurora, Colorado, United States (RECRUITING)
- University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Chiara Fabris, PhD — University of Virginia Center for Diabetes Technology
- Study coordinator: Jacqueline Rodriguez
- Email: ZMT8XG@uvahealth.org
- Phone: 434-422-2653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Routine Care, Routine Care + Glycemic Excursion Minimization, Continuous Glucose Monitor, Randomized Controlled Trial, Blood Glucose, Newly Diagnosed Type 2 Diabetes, Type 2 diabetes