Technology-assisted Case Management in Adults With Type 2 Diabetes (TACM-DM)

July 10, 2024 updated by: Leonard Ehianu Egede, State University of New York at Buffalo

Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes

The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long-term goal is to develop a practical and sustainable system of diabetes management that will help low income patients achieve and maintain goals within established treatment guidelines regardless of geographic location. This randomized clinical trial will employ the innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management (TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM). The target population will be low income patients served in Federally Qualified Health Care Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care) and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6 months, with study visits at baseline, 3, and 6 months. The primary outcome will be Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be blood pressure control and quality of life (qol) at 6 months post-randomization.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Franklin C. Fetter Family Health Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years and receiving care within the Franklin C. Fetter Family Health Center
  • Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
  • Subject must be willing to use the FORA 2-in-1 system
  • Subject must have a working land-line for the duration of the study in order to be able to upload the readings from the FORA 2-in-1 machine
  • Subjects must be able to communicate in English

Exclusion Criteria:

  • Mental confusion on interview suggesting significant dementia
  • Participation in other diabetes clinical trials
  • Alcohol or drug abuse/dependency using a screening questionnaire
  • Active psychosis or acute mental disorder
  • Life expectancy <6 months
  • Pregnant and/or lactating females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
The usual care group received the current standards of care at the study clinics.
Experimental: Technology Assisted Case Management
The TACM group used the FORA 2-in-1 Telehealth system for diabetes management intervention to link a case manager to patients with poorly controlled type 2 diabetes in real time.
Behavioral: Technology-Assisted Case Management
The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse case manager will have access to a secure server to which the uploaded measurements are stored in real time. Medications are titrated under supervision of a primary care and endocrinology physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
Time Frame: 6 months post randomization
Hemoglobin A1c (HbA1c) was measured at 6 months post randomization
6 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Leonard E Egede, MD, MS, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimated)

June 15, 2011

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00009204
  • Department of Defense (Other Grant/Funding Number: CP230185)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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