CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 450 enrolled
Drug / intervention
SMBGbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02033499
NCT02033499N/ACompleted

Effect of Glucose Monitoring on Patient and Provider Outcomes in Non-insulin Treated Diabetes

University of North Carolina, Chapel Hill·interventional·Posted Jan 10, 2014·Updated Dec 14, 2017

In Brief

A clinical study evaluating SMBG for DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder). Completed, enrolled 450 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 10, 2014
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.5 years ago

Interventions

SMBGbehavioral

Blood glucose levels are tested once daily.