DiabetesTACM-DMNCT01373489
Technology-assisted Case Management in Adults With Type 2 Diabetes
A study testing Technology-Assisted Case Management in people with Diabetes, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Technology-Assisted Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin C. Fetter Family Health Center, Inc.
Charleston, South Carolina, 29403
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Technology-Assisted Case Management
- Keywords
- type 2 diabetes, nurse case management, telemedicine
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Assisted Case ManagementBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | The usual care group received the current standards of care at the study clinics. |
| Technology Assisted Case Management | Experimental | 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. Receives: Behavioral: Technology-Assisted Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
Hemoglobin A1c (HbA1c) was measured at 6 months post randomization
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Leonard Ehianu Egede, State University of New York at Buffalo
- Investigators
- Leonard E Egede, MD, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373489
- Sponsor's protocol ID
- Pro00009204
- Other IDs
- Department of Defense
- Acronym
- TACM-DM
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2011
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22014122Egede 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.
PubMed 28581821
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01373489
- Acronym / sponsor ID
- TACM-DM / Pro00009204
- Conditions
- Diabetes
- Keywords
- type 2 diabetes, nurse case management, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jul 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Posted 17 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –The usual care group received the current standards of care at the study clinics. |
| Technology Assisted Case Management | Experimental | Behavioral: Technology-Assisted Case ManagementThe 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-Assisted Case ManagementThe 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 | Behavioural | Technology Assisted Case Management |
Primary outcome
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization
Time frame: 6 months post randomization
Hemoglobin A1c (HbA1c) was measured at 6 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22014122Egede 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.
- Results publication: PubMed 28581821Egede 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.
- Protocol PaperLink provided by the sponsor.
- Primary Outcomes PaperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard E Egede, MD, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Assisted Case Management in people with Diabetes, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization (time frame: 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373489, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.