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

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ClinicalTrials.gov Identifier: NCT01373489
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : September 30, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes Device: Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
Study Start Date : July 2011
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Usual Care
Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.
Active Comparator: Technology-assisted Case Management (TACM)
This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach.
Device: Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System)
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.

Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 months ]
    Hemoglobin A1C: Blood specimens will be obtained at baseline, 3 and 6 months visits by the Registered Nurse (RN). About 10cc of blood will be drawn and sent to the laboratory for hemoglobin A1C.

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 6 months ]
    Blood pressure measurement: Blood pressure readings will be obtained at baseline, 3 and 6 months visits by the RN using automated BP monitors (OMRON IntelliSenseTM HEM-907XL) with the patient seated comfortably for 5 minutes prior to the measurements, following the American Heart Association guidelines. The device will be programmed to take 5 readings at 2 minute intervals, after an initial rest period of 3 minutes.

  2. Quality of Life [ Time Frame: 6 months ]
    Quality of Life: The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status. It is a widely used brief (1-page, 2-minute) and comprehensive survey that yields summary physical (PCS-12) and mental health (MCS-12) outcome scores that are interchangeable with those from the SF-36 in both general and specific populations. The SF-12 items reproduce at least 90% of the variance in PCS-36 and MCS-36 scores.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373489

United States, South Carolina
Franklin C. Fetter Family Health Center, Inc.
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
United States Department of Defense
Principal Investigator: Leonard E Egede, MD, MS Medical University of South Carolina
More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01373489     History of Changes
Other Study ID Numbers: Pro00009204
Department of Defense ( Other Grant/Funding Number: W81XWH-10-2-0057 )
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016

Keywords provided by Medical University of South Carolina:
type 2 diabetes
nurse case management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases