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Integrated Diabetes Care for Type 2 Diabetes

N/A

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline HbA1c

Secondary outcome measures

Change from baseline blood pressure

Change from baseline diabetes distress

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

+14 more

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 / 3Eligibility criteria met

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Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

241 Previous Clinical Trials

56,448 Total Patients Enrolled

Media Library

iDSMES Clinical Trial Eligibility Overview. Trial Name: NCT05097534 — N/A

Type 2 Diabetes Research Study Groups: iDSMES, Standard of Care

Type 2 Diabetes Clinical Trial 2023: iDSMES Highlights & Side Effects. Trial Name: NCT05097534 — N/A

iDSMES 2023 Treatment Timeline for Medical Study. Trial Name: NCT05097534 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria that would disqualify me from participating in this investigation?

"The research team seeks 150 individuals aged 13 to 84 with type 2 diabetes mellitus. Suitable candidates must possess a body-mass index of 23 or higher (25 for non-Asians)."

Answered by AI

Are additional participants being accepted for this study?

"As per the clinicaltrials.gov's database, this study is not currently accepting patients; it was initially posted on December 7th 2021 and most recently modified in late December of that same year. Although no longer recruiting participants for its trial, 1392 other studies are looking for volunteers at present."

Answered by AI

Are geriatric participants eligible for this research study?

"This trial is open to members of the public aged between 13 and 84. There are 192 clinical trials for minors, while 1067 studies cater towards those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston

2021. "A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05097534.

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