Objectives: We report the 10-year effectiveness and within-trial cost-effectiveness of the Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) interventions among participants who were adherent to the interventions. Study Design: DPP was a 3-year randomized clinical trial followed by 7 years of open-label modified intervention follow-up. Methods: Data on resource utilization, cost, and quality of life were collected prospectively. Economic analyses were performed from health system and societal perspectives. Lifestyle adherence was defined as achieving and maintaining a 5% reduction in initial body weight, and metformin adherence as taking metformin at 80% of study visits. Results: The relative risk reduction was 49.4% among adherent lifestyle participants and 20.8% among adherent metformin participants compared with placebo. Over 10 years, the cumulative, undiscounted, per capita direct medical costs of the interventions, as implemented during the DPP, were greater for adherent lifestyle participants ($4810) than adherent metformin participants ($2934) or placebo ($768). Over 10 years, the cumulative, per capita non-interventionrelated direct medical costs were $4250 greater for placebo participants compared with adherent lifestyle participants and $3251 greater compared with adherent metformin participants. The cumulative quality-adjusted life-years (QALYs) accrued over 10 years were greater for lifestyle (6.80) than metformin (6.74) or placebo (6.67). Without discounting, from a modified societal perspective (excluding participant time) and a full societal perspective (including participant time), lifestyle cost < $5000 per QALY-gained and metformin was cost saving compared with placebo. Conclusions: Over 10 years, lifestyle intervention and metformin were cost-effective or cost saving compared with placebo. These analyses confirm that lifestyle and metformin represent a good value for money.
[Show abstract][Hide abstract] ABSTRACT: To inform the design and assess the feasibility of a prospective effectiveness study evaluating an insulin delivery device for patients with diabetes mellitus to be conducted within the membership of a large US commercial insurer.
Providers who issued ≥1 insulin prescription between January 1, 2011 and September 30, 2011 were selected from administrative claims contained in the HealthCore Integrated Research Database(SM). Adult diabetes patients with visits to these providers were identified. Providers were dichotomized into high- (HVPs) and low-volume providers (LVPs) based on median number of diabetes patients per provider.
We identified 15,349 HVPs and 15,313 LVPs (median number of patients = 14). Most HVPs were located in the Midwest (6,291 [41.0%]) and South (5,092 [33.2%]), while LVPs were evenly distributed across regions. Over 80% (12,769) of HVPs practiced family or internal medicine; 6.4% (989) were endocrinologists. HVPs prescribed insulin to an average of 25% of patients. Patients of HVPs (522,527) had similar characteristics as patients of LVPs (80,669), except for geographical dispersion, which followed that of providers. Approximately 65% of patients were aged 21-64 years and 97% had type 2 diabetes. Among patients with ≥1 available HbA1C result during 2011 (103,992), 48.3% (50,193) had an average HbA1C ≥7.0%. Among patients initiating insulin, 79.6% (22,205) had an average HbA1C ≥7.0%.
The observed provider and patient populations support the feasibility of the prospective study. Sampling of patients from HVPs is efficient while minimizing bias as patient characteristics are similar to those from LVPs. The study also highlights unmet needs for improved glycemic control since approximately half of patients with diabetes are not on goal.
ClinicoEconomics and Outcomes Research 09/2013; 5(1):471-479. DOI:10.2147/CEOR.S46896
[Show abstract][Hide abstract] ABSTRACT: A clinical study was designed that aimed to analyze whether resection of the large bowel in cancer patients might benefit diabetes mellitus.
This prospective case-control study included retrospective information. Patients (n = 247) included diabetic and euglycemic groups with colorectal cancer operations (n = 60), cancer gastrectomy (n = 72), exclusive chemoradiotherapy for rectal cancer (n = 46), and noncancer clinical controls (n = 69). Follow-up periods were, respectively, 79.2 ± 27.4, 86.8 ± 25.1, 70.0 ± 26.3, and 85.1 ± 18.2 months (NS). Diabetes groups included patients with prediabetes.
Diabetes remission, defined as conversion from diabetes to prediabetes or from this condition to normal, was documented in, respectively, 32.4 % (11 of 34), 41.2 % (14 of 34), 7.1 % (1 of 14), and 7.7 % (3 of 39) in the four cohorts (P = 0.004). Within the same period, progression of euglycemic participants to diabetes occurred in 30.8 % (8 of 26), 63.2 % (24 of 38), 25.0 (8 of 32), and 20.0 % (6 of 30) (P = 0.028). Diabetes amelioration was associated with weight loss in gastrectomy patients but not in the other groups. Dietary intake, estimated in the two surgical populations, did not predict outcome.
Diabetes amelioration after colorectal interventions was demonstrated, but progression of euglycemic patients toward prediabetes was not changed in comparison with nonsurgical controls. It is speculated that reshaping of the bowel microbiome or hormone changes after colorectal interventions underlay the improvement in diabetes. Body weight fluctuations could not be incriminated in this investigation.
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE
This study uses novel methods to examine the frequency of diagnosis and treatment of prediabetes in real-world clinical settings using electronic health record (EHR) data.RESEARCH DESIGN AND METHODS
We identified a cohort of 358,120 adults with incident prediabetes (fasting plasma glucose [FPG] 100-125 mg/dL or glycated hemoglobin 5.7-6.4% [39-46 mmol/mol]) between 2006 and 2010 and examined rates of diagnosis and treatment in the 6 months post-identification.RESULTSIn the 6 months after identification of prediabetes, 18% of patients had their blood glucose levels retested; 13% received a physician diagnosis of prediabetes/hyperglycemia; 31.0% had prediabetes, diabetes, or lifestyle documented in the clinical notes; and <0.1% initiated metformin. Among patients with FPG 120-125 mg/dL, 31% were retested; metformin initiation remained <1%.CONCLUSIONS
Documented rates of follow-up and treatment for prediabetes are low. EHR data may be a valuable tool to improve identification and treatment of prediabetes in the U.S.
Diabetes care 11/2013; 37(2). DOI:10.2337/dc13-1223 · 8.42 Impact Factor
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