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Effect of glucose monitoring on patient and provider outcomes in non-insulin-treated diabetes
Investigator (PI): Donahue, Katrina
Performing Organization (PO): (Current): University of North Carolina at Chapel Hill, School of Medicine, Diabetes Center for Research / (919) 966-0134
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2017
Record Source/Award ID: PCORI/CE-12-11-4980
Funding: Total Award Amount: $2,099,799
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Number of Subjects: 450
Abstract: For the nearly 75% of patients living with type 2 diabetes (T2DM) who do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) is unclear. SMBG testing is a resource-intensive activity without firmly established patient benefits. While SMBG holds great promise for sparking favorable behavioral 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 clinically 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 following each SMBG testing event delivered to the patient through the glucose meter. The first two arms represent common SMBG testing approaches currently being used. The third arm is an enhanced, patient-centered approach to SMBG testing. SMBG values will be evaluated at routine clinic visits over 52 weeks. The following primary outcomes will be assessed: quality of life and glycemic control. We will assess differences across the following pre-specified subgroups: (1) prior experience using SMBG; (2) duration of T2DM; (3) baseline degree of glycemic control; (4) anti-hyperglycemic treatment; (5) age; (6) race/ethnicity; and (7) health literacy. Secondary outcomes will include diabetes-related treatment satisfaction, diabetes self-efficacy, diabetes distress, self-care, hypoglycemia frequency, and patient-provider communication. Using qualitative methods, we will assess health care providers' attitudes and experiences with using the automated system to deliver SMBG results within the real-world, busy clinic setting. Given the time- and resource-intensive nature of SMBG and the rapidly growing prevalence of T2DM, the practice of medicine is overdue for a pragmatic assessment of the utility of SMBG in everyday, routine clinical practice that evaluates outcomes of central importance to patients living with the disease.
MeSH Terms:
  • Automation
  • Blood Glucose /analysis
  • Blood Glucose Self-Monitoring /*methods
  • Diabetes Mellitus, Type 2 /*diagnosis
  • /*drug therapy /psychology
  • Electronic Data Processing
  • Health Behavior
  • Humans
  • Hypoglycemic Agents /therapeutic use
  • Insulin /*therapeutic use
  • Outcome Assessment (Health Care)
  • Patient-Centered Care
  • Prevalence
  • Professional-Patient Relations
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Time Factors
Country: United States
State: North Carolina
Zip Code: 27599
UI: 20143264
CTgovId: NCT02033499
Project Status: Completed
Record History: ('2017: Project extended to 2017',)