Effectiveness and Cost-Effectiveness of Diabetes Prevention Among Adherent Participants
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: Background: Detection of type 2 diabetes (T2D) is routinely based on the presence of dysglycemia. Although disturbed lipid metabolism is a hallmark of T2D, the potential of plasma lipidomics as a biomarker of future T2D is unknown. Our objective was to develop and validate a plasma lipidomic risk score (LRS) as a biomarker of future type 2 diabetes and to evaluate its cost-effectiveness for T2D screening. Methods: Plasma LRS, based on significantly associated lipid species from an array of 319 lipid species, was developed in a cohort of initially T2D-free individuals from the San Antonio Family Heart Study (SAFHS). The LRS derived from SAFHS as well as its recalibrated version were validated in an independent cohort from Australia - the AusDiab cohort. The participants were T2D-free at baseline and followed for 9197 person-years in the SAFHS cohort (n = 771) and 5930 person-years in the AusDiab cohort (n = 644). Statistically and clinically improved T2D prediction was evaluated with established statistical parameters in both cohorts. Modeling studies were conducted to determine whether the use of LRS would be cost-effective for T2D screening. The main outcome measures included accuracy and incremental value of the LRS over routinely used clinical predictors of T2D risk; validation of these results in an independent cohort and cost-effectiveness of including LRS in screening/intervention programs for T2D. Results: The LRS was based on plasma concentration of dihydroceramide 18:0, lysoalkylphosphatidylcholine 22:1 and triacyglycerol 16:0/18:0/18:1. The score predicted future T2D independently of prediabetes with an accuracy of 76 %. Even in the subset of initially euglycemic individuals, the LRS improved T2D prediction. In the AusDiab cohort, the LRS continued to predict T2D significantly and independently. When combined with risk-stratification methods currently used in clinical practice, the LRS significantly improved the model fit (p < 0.001), information content (p < 0.001), discrimination (p < 0.001) and reclassification (p < 0.001) in both cohorts. Modeling studies demonstrated that LRS-based risk-stratification combined with metformin supplementation for high-risk individuals was the most cost-effective strategy for T2D prevention. Conclusions: Considering the novelty, incremental value and cost-effectiveness of LRS it should be used for risk-stratification of future T2D.
- "DPP Trial [32, 33]. We cumulated the first five years data from the DPP Trial in individuals undergoing Lifestyle intervention, Metformin supplementation or No intervention (placebo) group. "
- [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.
- [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.