Reducing blood sugar spikes in early type 2 diabetes through lifestyle changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.