Diabetes technology & therapeutics
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Diabetes Technol. Ther. · Sep 2019
Multicenter StudySotagliflozin Added to Optimized Insulin Therapy Leads to Lower Rates of Clinically Relevant Hypoglycemic Events at Any HbA1c at 52 Weeks in Adults with Type 1 Diabetes.
Background: Hypoglycemia rates usually increase when insulin treatment is intensified to improve glycemic control. We evaluated (post hoc) hypoglycemic rates in adult patients with type 1 diabetes (T1D) on sotagliflozin (a dual sodium-glucose cotransporter [SGLT] 1 and 2 inhibitor) in two phase 3, 52-week clinical trials (inTandem 1 and 2; NCT02384941 and NCT02421510). Materials and Methods: We analyzed rates of documented hypoglycemia (level 1, blood glucose ≥54 to <70 mg/dL) and clinically important hypoglycemia (level 2, glucose <54 mg/dL) in a patient-level pooled analysis (n = 1362) using a negative binomial model adjusted for hemoglobin A1c (HbA1c) at 52 weeks in patients receiving placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg. ⋯ The difference in rates of hypoglycemia with sotagliflozin versus placebo became more pronounced as HbA1c decreased. Conclusions: At week 52, level 1 and 2 hypoglycemia events were 22% to 30% less frequent with sotagliflozin added to optimized insulin therapy versus placebo in adults with T1D at any HbA1c level, with greater differences at lower HbA1c values. These findings support the use of sotagliflozin as an insulin adjunct in T1D.
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Diabetes Technol. Ther. · Sep 2019
Comparative StudyHuman Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation.
Background: A room-temperature stable, soluble liquid glucagon formulation loaded into a prefilled, single-use, two-step autoinjector is under development for severe hypoglycemia rescue. We report a human factors validation program evaluating the glucagon autoinjector (GAI) (Gvoke HypoPen™; Xeris Pharmaceuticals, Inc., Chicago, IL) versus marketed glucagon emergency kits (GEKs) for managing severe hypoglycemia. Methods: A simulated-use human factors usability study was conducted with the GAI versus marketed GEKs in 16 participants, including adult caregivers and first responders, experienced with glucagon administration. ⋯ In the validation study, 98.7% successfully administered the rescue injection using the GAI. Overall, there were no patterns of differences between trained versus untrained participants, between caregivers versus first responders or between adults versus adolescents. Conclusion: The GAI and instructional materials can be correctly, safely, and effectively used by intended user, which support continued development of the GAI as an alternative to GEKs.
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Diabetes Technol. Ther. · Aug 2019
Long-Term Effectiveness of Continuous Subcutaneous Insulin Infusion in the Prevention of Hypoglycemia in Adults with Type 1 Diabetes.
Background: Reducing hyperglycemia while avoiding hypoglycemia is the key clinical goal in managing people with type 1 diabetes. Insulin delivery techniques and regimens are constantly evolving to achieve these goals. At present, use of multiple daily injections (MDI) is the standard of care, but there is increasing interest in continuous subcutaneous insulin infusion (CSII). ⋯ Self-monitoring blood glucose data showed significantly less hypoglycemia with CSII by over 30%, occurring as early as the first year and sustained throughout the follow-up period (P < 0.001). This benefit of CSII on reducing hypoglycemia was independent of more frequent hypoglycemia and higher body weight at baseline, factors that were also independently associated with reduced hypoglycemia. Conclusions: In selected adults with type 1 diabetes, long-term CSII can provide long-term clinically relevant and sustained reductions in hypoglycemia, particularly in those with greater initial risk of hypoglycemia and higher body weight, and improved glycemic control compared with MDI.
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Diabetes Technol. Ther. · Apr 2019
Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert.
Programmable and fixed auditory and/or vibratory threshold alerts are essential features of real-time continuous glucose monitoring (rtCGM) systems that provide users time to intervene before the onset of clinical hypoglycemia or hyperglycemia. A sixth-generation rtCGM system from Dexcom, Inc. (G6) includes a new alert that is triggered when an algorithm predicts that an estimated glucose value ≤55 mg/dL will occur within 20 min, allowing users more time to act to avoid hypoglycemia. We examined whether this predictive low glucose alert provided added benefit to traditional low threshold alerts. ⋯ Advance warning provided by predictive low glucose alerts may further reduce hypoglycemia among rtCGM-experienced users.
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Diabetes Technol. Ther. · Jan 2019
Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes.
We investigated the efficacy and safety of continuous glucose monitoring (CGM) initiation within 1 year of type 1 diabetes (T1D) diagnosis among children, adolescents, and adults. ⋯ Irrespective of insulin delivery system, early initiation of CGM within 1 year from T1D diagnosis was associated with better glucose control and fewer diabetes-related emergency visits.