Technology-assisted Case Management in Adults With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Technology-Assisted Case Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>The usual care group received the current standards of care at the study clinics. | |
| Experimental: Technology Assisted Case Management<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, nurse case management, telemedicine