Michael J. O'Grady

Continuous glucose monitoring and intensive treatment of type 1 diabetes

BACKGROUNDnThe value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined.nnnMETHODSnIn a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks.nnnRESULTSnThe changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference.nnnCONCLUSIONSnContinuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)

Projecting the Future Diabetes Population Size and Related Costs for the U.S.

OBJECTIVE We developed a novel population-level model for projecting future direct spending on diabetes. The model can be used in the federal budget process to estimate the cost implications of alternative policies. RESEARCH DESIGN AND METHODS We constructed a Markov model simulating individuals movement across different BMI categories, the incidence of diabetes and screening, and the natural history of diabetes and its complications over the next 25 years. Prevalence and incidence of obesity and diabetes and the direct spending on diabetes care and complications are projected. The study population is 24- to 85-year-old patients characterized by the Centers for Disease Control and Preventions National Health and Nutrition Examination Survey and National Health Interview Survey. RESULTS Between 2009 and 2034, the number of people with diagnosed and undiagnosed diabetes will increase from 23.7 million to 44.1 million. The obesity distribution in the population without diabetes will remain stable over time with ∼65% of individuals of the population being overweight or obese. During the same period, annual diabetes-related spending is expected to increase from

The effect of continuous glucose monitoring in well-controlled type 1 diabetes.

113 billion to

Economic model of a birth cohort screening program for hepatitis C virus

336 billion (2007 dollars). For the Medicare-eligible population, the diabetes population is expected to rise from 8.2 million in 2009 to 14.6 million in 2034; associated spending is estimated to rise from

The Cost-Effectiveness of Continuous Glucose Monitoring in Type 1 Diabetes

45 billion to

Health utilities for children and adults with type 1 diabetes.

171 billion. CONCLUSIONS The diabetes population and the related costs are expected to at least double in the next 25 years. Without significant changes in public or private strategies, this population and cost growth are expected to add a significant strain to an overburdened health care system.

Policy Implications of First-Dollar Coverage: A Qualitative Examination from the Payer Perspective

OBJECTIVE The potential benefits of continuous glucose monitoring (CGM) in the management of adults and children with well-controlled type 1 diabetes have not been examined. RESEARCH DESIGN AND METHODS A total of 129 adults and children with intensively treated type 1 diabetes (age range 8–69 years) and A1C <7.0% were randomly assigned to either continuous or standard glucose monitoring for 26 weeks. The main study outcomes were time with glucose level ≤70 mg/dl, A1C level, and severe hypoglycemic events. RESULTS At 26 weeks, biochemical hypoglycemia (≤70 mg/dl) was less frequent in the CGM group than in the control group (median 54 vs. 91 min/day), but the difference was not statistically significant (P = 0.16). Median time with a glucose level ≤60 mg/dl was 18 versus 35 min/day, respectively (P = 0.05). Time out of range (≤70 or >180 mg/dl) was significantly lower in the CGM group than in the control group (377 vs. 491 min/day, P = 0.003). There was a significant treatment group difference favoring the CGM group in mean A1C at 26 weeks adjusted for baseline (P < 0.001). One or more severe hypoglycemic events occurred in 10 and 11% of the two groups, respectively (P = 1.0). Four outcome measures combining A1C and hypoglycemia data favored the CGM group in comparison with the control group (P < 0.001, 0.007, 0.005, and 0.003). CONCLUSIONS Most outcomes, including those combining A1C and hypoglycemia, favored the CGM group. The weight of evidence suggests that CGM is beneficial for individuals with type 1 diabetes who have already achieved excellent control with A1C <7.0%.

How might immunization rates change if cost sharing is eliminated

Recent research has identified high hepatitis C virus (HCV) prevalence among older U.S. residents who contracted HCV decades ago and may no longer be recognized as high risk. We assessed the cost‐effectiveness of screening 100% of U.S. residents born 1946‐1970 over 5 years (birth‐cohort screening), compared with current risk‐based screening, by projecting costs and outcomes of screening over the remaining lifetime of this birth cohort. A Markov model of the natural history of HCV was developed using data synthesized from surveillance data, published literature, expert opinion, and other secondary sources. We assumed eligible patients were treated with pegylated interferon plus ribavirin, with genotype 1 patients receiving a direct‐acting antiviral in combination. The target population is U.S. residents born 1946‐1970 with no previous HCV diagnosis. Among the estimated 102 million (1.6 million chronically HCV infected) eligible for screening, birth‐cohort screening leads to 84,000 fewer cases of decompensated cirrhosis, 46,000 fewer cases of hepatocellular carcinoma, 10,000 fewer liver transplants, and 78,000 fewer HCV‐related deaths. Birth‐cohort screening leads to higher overall costs than risk‐based screening (

The Role of the Federal Statistical System in Evidence-based Policymaking, or How to Make the Statistical System Essential

80.4 billion versus

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. The effect of continuous glucose monitoring in well-controlled type 1 diabetes

53.7 billion), but yields lower costs related to advanced liver disease (