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Purpose: To inform the design and assess the feasibility of a prospective effectiveness study evaluating a delivery device for insulin among patients with diabetes mellitus (DM) to be conducted within the membership of a large US commercial insurer.
Methods: Providers with ≥1 prescription for insulin between 01/01/2011 and 09/30/2011 were selected from the HealthCore Integrated Research Database. Diabetes patients with encounters among these providers and continuous eligibility throughout 2011 were identified. Providers were dichotomized into high- [HVPs] and low-volume groups [LVPs] based on the median number of DM patients per provider.
Results: We identified 15,491 HVPs and 15,200 LVPs (median number of patients=14). Most HVPs located in the Midwest (N=6,342 [40.9%]) and South (N=5,146 [33.2%]), while LVPs were evenly distributed across regions. Over 80% (N=12,756) of HVPs practiced family or internal medicine, while approximately 6.5% (N=999) were endocrinologists. Metformin was the most commonly prescribed oral antidiabetic (39% ±13% of patients with ≥1 fill per provider). HVPs prescribed insulin to an average of 26% (±14%) of their patients. Patients of HVPs (N=524,086) had similar characteristics to patients of LVPs (N=79,725), except for geographical dispersion, which followed those of providers. Approximately 66% of patients were aged 18-64 and 95% had type 2 DM. Among patients with ≥1 available HbA1C result during 2011 (N=103,961), 48% (N=50,268) had an average HbA1C ≥7.0%. Among these uncontrolled patients, 44% (N=22,354) received ≥1 insulin prescription.
Conclusion: The observed provider and patient populations support the feasibility of the prospective study. Sampling of patients from HVPs is efficient while minimizing bias as patients are similar in characteristics to those from LVPs. The study also highlights unmet need for improved glycemic control since approximately half of DM patients are not on goal.