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Automated Health Coaching for Type 2 Diabetes (GODART-P&F Trial)

N/A
Recruiting
Led By Mohanraj Thirumalai, PHD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Diagnosis of T2DM
Must not have
Renal failure in the past 6 months
Patients currently on insulin treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a low-cost AI-assisted lifestyle intervention for diabetes in rural areas, which is delivered via landline phone. It will provide knowledge to develop an optimal intervention package in the future.

Who is the study for?
This trial is for adults over 18 with Type 2 Diabetes, who speak and read English, have a doctor's approval to join, and HbA1c levels between 7% to 10.5%. It's not for those pregnant or planning pregnancy, in another diabetes study, on insulin treatment, with recent renal failure or major heart events.
What is being tested?
The study tests an AI-assisted lifestyle change program aimed at controlling blood sugar in rural areas via regular phone service. Participants receive either automated or human health coaching weekly with varying reward systems to see which method works best.
What are the potential side effects?
Since the interventions involve lifestyle modifications through coaching rather than medication, typical medical side effects are not expected. However, participants may experience stress or frustration if they find it difficult to adhere to the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had renal failure in the last 6 months.
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I am currently being treated with insulin.
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I have not had a major heart problem in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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 in Hemoglobin A1C level between screening and 6 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 4Experimental Treatment2 Interventions
Fixed Reward + Weekly human coaching
Group II: Arm 3Experimental Treatment2 Interventions
Fixed Reward + Weekly automated coaching
Group III: Arm 2Experimental Treatment2 Interventions
Adaptive Rewards + Weekly human coaching
Group IV: Arm 1Experimental Treatment2 Interventions
Adaptive Rewards + Weekly automated coaching

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,744 Total Patients Enrolled
15 Trials studying Diabetes
41,298 Patients Enrolled for Diabetes
Mohanraj Thirumalai, PHDPrincipal InvestigatorUniversity of Alabama at Birmingham
Tapan Mehta, PHDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Arm 4 Clinical Trial Eligibility Overview. Trial Name: NCT05344859 — N/A
Diabetes Research Study Groups: Arm 4, Arm 2, Arm 3, Arm 1
Diabetes Clinical Trial 2023: Arm 4 Highlights & Side Effects. Trial Name: NCT05344859 — N/A
Arm 4 2023 Treatment Timeline for Medical Study. Trial Name: NCT05344859 — N/A
~20 spots leftby Mar 2025
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