Integrated Diabetes Care for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Texas Medical Branch, Galveston

Trial Summary

What is the purpose of this trial?To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.

Eligibility Criteria

This trial is for people aged 13-84 with type 2 diabetes, who have a Hemoglobin A1c value of at least 7% and a BMI of at least 25 (or 23 for Asians). It's not suitable for those unable to commit to a year-long study, planning to move away from the area, pregnant women, prisoners, or anyone with conditions that could affect their survival.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

My BMI is 25 or higher (23 if I'm Asian).

Your hemoglobin A1c level is 7% or higher.

+1 more

Exclusion Criteria

I am younger than 13 or older than 84.

Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.

My health conditions or medications do not disqualify me from the study.

+3 more

Participant Groups

The study compares standard diabetes care against an integrated model called iDSMES. Participants in the iDSMES group will receive comprehensive support including dietary counseling and various therapies aimed at improving self-management of diabetes over one year.

2Treatment groups

Active Control

Placebo Group

Group I: iDSMESActive Control1 Intervention

Eligible study subjects randomized to the intervention arm will receive: A. Intensive Diabetes Self-Management, Education, and Support (iDSMES). Participants will be enrolled in groups in a virtual or in-person setting with their lifestyle coach, in this one-year educational program B. Services addressing Social Determinants of Health All study subjects will have their data collected at time points around baseline, 6 months and 12 months from consenting including glycemic control, hypertension management, dyslipidemia management, prevention or management of complications, healthcare outcomes, lifestyle change outcomes, patient-centeredness outcomes, Secondary diabetes self-management behaviors, self-efficacy in managing diabetes, diabetes distress, and Morisky Green Levine Medication Adherence Scale.

Group II: Standard of CarePlacebo Group1 Intervention

Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.