Technology-assisted Case Management in Adults With Type 2 Diabetes

Diabetes Clinical Trial

— TACM-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373489
• Other study ID #: Pro00009204
• Secondary ID: Department of De
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: August 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Franklin C. Fetter Family Health Center, Inc.	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

Egede LE, Strom JL, Fernandes J, Knapp RG, Rojugbokan A. Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial. Trials. 2011 Oct 20;12:231. doi: 10.1186/1745-6215-12-231. — View Citation

Egede LE, Williams JS, Voronca DC, Knapp RG, Fernandes JK. Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes. Diabetes Technol Ther. 2017 Aug;19(8):476-482. doi: 10.1089/dia.2017.0006. Epub 2017 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c) at 6 Months Post Randomization	Hemoglobin A1c (HbA1c) was measured at 6 months post randomization	6 months post randomization

External Links

•   Primary Outcomes Paper
•   Protocol Paper