Status:

COMPLETED

GODART Pilot and Feasibility

Lead Sponsor:

University of Alabama at Birmingham

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural po...

Detailed Description

Evidence-based guidelines for type 2 diabetes mellitus (T2DM) management aimed at glycemic control (reduced hemoglobin A1c) include a combination of diet, physical activity (PA), glucose monitoring, a...

Eligibility Criteria

Inclusion

  • a diagnosis of T2DM
  • HbA1C ≥7% to ≤ 10.5% for phase 1- 14 days and phase 2 of the study- 6 months.
  • ≥18 years of age
  • the ability to converse in and read English.

Exclusion

  • Present or soon-planned pregnancy
  • Current enrollment in any structured lifestyle intervention study for diabetes or weight management.
  • Patients currently on insulin treatment
  • Major cardiac event in the past 6 months
  • Renal failure in the past 6 months
  • Listening and Speaking Impairment

Key Trial Info

Start Date :

May 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 31 2025

Estimated Enrollment :

88 Patients enrolled

Trial Details

Trial ID

NCT05344859

Start Date

May 15 2023

End Date

October 31 2025

Last Update

December 17 2025

Active Locations (1)

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1

Department of Family and Community Medicine, University of Alabama at Birmingham

Birmingham, Alabama, United States, 35205