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NCT02033499 · ClinicalTrials.gov registry record · NA
Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 450
- Enrollment target
NCT02033499 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 450 participants.
The verdict
NCT02033499, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
Study Summary
For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) are unclear. SMBG testing is a resource intensive activity without firmly established patient benefits. While SMBG holds great promise for sparking favorable behavior change, the potential for no benefit or even patient harm must be acknowledged. Possible negative effects on patient quality of life must be more closely examined along with the speculative benefits of SMBG in non-insulin treated T2DM. Among studies examining this issue a general consensus is evolving; while SMBG may or may not be useful, its value can only be fully appreciated when the SMBG results are provided to patients in a useful manner. The overarching goal of this proposal is to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within the real-world, clinic setting. In this pragmatic trial, 450 patients will be randomized to one of the following three SMBG testing regimens: 1) no SMBG testing, 2) once daily SMBG testing with standard patient feedback consisting of glucose values being immediately reported to the patient through the glucose meter, and 3) once daily SMBG testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient plus automated, tailored feedback messaging. The first two arms represent common SMBG testing approaches. The third arm is an enhanced, patient-centered approach to SMBG testing. SMBG values will be evaluated at routine clinic visits over 52 weeks.
Interventions
- BEHAVIORAL SMBG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02033499
The ClinicalTrials.gov registry entry for NCT02033499 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SMBG is the first listed.
NCT02033499 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02033499 about?
NCT02033499 is a clinical study titled "Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes". For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) are unclear. SMBG testing is a resource intensive activity without firmly established patient benefits. While SMBG holds great promise for sparking f...
What is the current status of trial NCT02033499?
This trial is currently completed. It is a NA study. The enrollment target is 450 participants. The study started on 2014-01. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02033499?
The interventions under investigation include: SMBG (BEHAVIORAL).
Who is sponsoring clinical trial NCT02033499?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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