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Integrated Diabetes Care for Type 2 Diabetes

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Waitlist Available

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients have a BMI equal to or >25 (23, if Asians)

Patients diagnosed with type 2 diabetes

Must not have

Ages <13 or >84

Previous diagnosis of type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every session through study completion, an average of 1 year

Summary

This trial is testing an integrated model of care for patients with type 2 diabetes, to see if it improves diabetes self-management outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on education and lifestyle management rather than medication, side effects are minimal but may include discomfort from lifestyle changes or stress related to participation in the educational program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with type 2 diabetes.

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I am between 13 and 84 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 13 or older than 84.

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I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every session through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every session through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and every session through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline HbA1c

Secondary study objectives

Change from baseline blood pressure

Change from baseline diabetes distress

Change from baseline frequency of emergency care visits for treatment of T2-related issues

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Trial Design

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.

0 / 5Eligibility criteria met