International Consensus on Risk Management of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Treated With Sodium-Glucose Cotransporter (SGLT) Inhibitors.

Sodium-glucose cotransporter (SGLT) inhibitors are new oral antidiabetes medications shown to effectively reduce glycated hemoglobin (A1C) and glycemic variability, blood pressure, and body weight without intrinsic properties to cause hypoglycemia in people with type 1 diabetes. However, recent studies, particularly in individuals with type 1 diabetes, have demonstrated increases in the absolute risk of diabetic ketoacidosis (DKA). Some cases presented with near-normal blood glucose levels or mild hyperglycemia, complicating the recognition/diagnosis of DKA and potentially delaying treatment. Several SGLT inhibitors are currently under review by the U.S. Food and Drug Administration and European regulatory agencies as adjuncts to insulin therapy in people with type 1 diabetes. Strategies must be developed and disseminated to the medical community to mitigate the associated DKA risk. This Consensus Report reviews current data regarding SGLT inhibitor use and provides recommendations to enhance the safety of SGLT inhibitors in people with type 1 diabetes.

Extensive Assessment of Blood Glucose Monitoring During Postprandial Period and Its Impact on Closed-Loop Performance.

BACKGROUND: Closed-loop (CL) systems aims to outperform usual treatments in blood glucose control and continuous glucose monitors (CGM) are a key component in such systems. Meals represents one of the main disturbances in blood glucose control, and postprandial period (PP) is a challenging situation for both CL system and CGM accuracy. METHODS: We performed an extensive analysis of sensor's performance by numerical accuracy and precision during PP, as well as its influence in blood glucose control under CL therapy. RESULTS: During PP the mean absolute relative difference (MARD) for both sensors presented lower accuracy in the hypoglycemic range (19.4 ± 12.8%) than in other ranges (12.2 ± 8.6% in euglycemic range and 9.3 ± 9.3% in hyperglycemic range). The overall MARD was 12.1 ± 8.2%. We have also observed lower MARD for rates of change between 0 and 2 mg/dl. In CL therapy, the 10 trials with the best sensor spent less time in hypoglycemia (PG < 70 mg/dl) than the 10 trials with the worst sensors (2 ± 7 minutes vs 32 ± 38 minutes, respectively). CONCLUSIONS: In terms of accuracy, our results resemble to previously reported. Furthermore, our results showed that sensors with the lowest MARD spent less time in hypoglycemic range, indicating that the performance of CL algorithm to control PP was related to sensor accuracy.

Lifetime health consequences and cost-effectiveness of rosiglitazone in combination with metformin for the treatment of type 2 diabetes in Spain.

OBJECTIVE: To assess the lifetime diabetes health consequences and cost-effectiveness in Spain of rosiglitazone in combination with metformin for the treatment of type 2 diabetes in overweight and obese patients failing to maintain glycaemic control with metformin monotherapy compared with conventional care of metformin in combination with either sulfonylureas or bedtime insulin. RESEARCH DESIGN AND METHODS: The Diabetes Decision Analysis of Cost--Type 2 was adapted for clinical practice and healthcare funding in Spain, and was calibrated with Spanish epidemiological, healthcare resource use and cost data, taking the perspective of the Spanish National Health System. The model simulates lifetime treatment histories, complications and consequences of type 2 diabetes, and associated health outcomes and costs for age and sex-matched cohorts of 1000 overweight and obese patients. The primary health outcome measures compared are glycaemic control, time to insulin, incidence and prevalence of coronary heart disease, stroke, clinical nephropathy, ulceration and amputation, and severe visual loss, and incremental life-years and quality-adjusted life-years (QALYs). RESULTS: Rosiglitazone in combination with metformin produces better glycaemic control than conventional care of metformin in combination with either sulfonylureas or bedtime insulin in most patients, and extends the viability of combination therapy by between 6 and 13 years before requiring insulin. Rosiglitazone patients have a longer life expectancy, gaining between 106 and 175 additional life-years per 1000 patients, experience fewer episodes of coronary disease and clinical nephropathy, and live for longer periods free of complications. The improvements in morbidity and mortality are projected to yield between 134 and 238 additional QALY per 1000 patients over their lifetime. Discounted incremental cost-effectiveness ratios range from euro 9406 to euro 23,514 per QALY gained. CONCLUSION: The model predicts that rosiglitazone in combination with metformin is a cost-effective intervention for the treatment of both overweight and obese patients with type 2 diabetes when compared with conventional care in Spain.