Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes

Completed · Not applicable

Conditions studied: DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)

In brief

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.

Key facts

Study ID

NCT02033499

Run by

University of North Carolina, Chapel Hill

People needed

450

Starts

2014-01-01

Expected to finish

2016-09-01

Last updated by the study team

2017-12-14

Who can join

Age: 30 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of type 2 diabetes
• Age > 30
• An established patient at the participating UNC Physicians Network (UNCPN) practice who identifies a UNCPN health care provider within that practice as their primary provider of diabetes care.
• A1c >6.5% but <9.5% within the 6 months preceding the screening call/visit, as obtained from the patient's medical record.
• Willing to comply with the results of random assignment into a study group.

You may not qualify if…

• Currently sees or plans to see an endocrinologist or other diabetes specialist in the next year.
• Use of insulin
• Is or plans to become pregnant in the next 12 months.
• Plans to relocate in the next 12 months.
• Has other conditions (e.g. renal or cardiovascular disease, poor visual acuity), other factors (e.g. frailty,) or comorbidities (e.g. cancer) that might put the patient at risk when following study protocols.
• No history of significant issues with known or suspected hypoglycemia or any history of "severe" hypoglycemia (requiring assistance from a third party).

Where it is running

• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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