Technology-assisted Case Management in Adults With Type 2 Diabetes
TACM-DM
Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
2 other identifiers
interventional
113
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Jul 2011
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
August 17, 2018
CompletedJuly 12, 2024
July 1, 2024
4.9 years
June 13, 2011
June 12, 2018
July 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
Hemoglobin A1c (HbA1c) was measured at 6 months post randomization
6 months post randomization
Study Arms (2)
Usual Care
NO INTERVENTIONThe usual care group received the current standards of care at the study clinics.
Technology Assisted Case Management
EXPERIMENTALThe 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Franklin C. Fetter Family Health Center, Inc.
Charleston, South Carolina, 29403, United States
Related 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.
PMID: 22014122BACKGROUNDEgede 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 Jun 5.
PMID: 28581821RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Campbell
- Organization
- Medical College of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard E Egede, MD, MS
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Chair, Department of Medicine
Study Record Dates
First Submitted
June 13, 2011
First Posted
June 15, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 12, 2024
Results First Posted
August 17, 2018
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share