NASAL GLUCAGON DELIVERY IS MORE SUCCESSFUL THAN INJECTABLE DELIVERY: A SIMULATED SEVERE HYPOGLYCEMIA RESCUE.

Objective: A severe hypoglycemia (SH) episode is an acute, high-stress moment for the caregivers of persons with diabetes (PWD). We compared the success rates of nasal glucagon (NG) and injectable glucagon (IG) administration for PWD-trained and untrained users in treating simulated SH episodes. Methods: Thirty-two PWD-trained users and 33 untrained users administered NG and IG to high-fidelity manikins simulating treatment of an SH emergency. Simulation rooms resembled common locations with typical diabetic supplies and stressor elements mimicking real-life SH environments. Success rate and time to administer glucagon were measured. Results: Of all the PWD-trained and untrained users, 58/64 (90.6%) could successfully deliver NG, while 5/63 (7.9%) could successfully deliver IG. For NG simulations, 28/31 (90.3%) PWD-trained users and 30/33 (90.9%) untrained users could successfully administer the dose (mean time 47.3 seconds and 44.5 seconds, respectively). For IG simulations, 5/32 (15.6%) PWD-trained users successfully injected IG (mean time 81.8 seconds), whereas none (0/31 [0%]) of the untrained users were successful. Reasons for unsuccessful administration of NG included oral administration and incomplete pushing of the device plunger. For IG, inability to perform reconstitution steps, partial dose delivery, and injection at an inappropriate site were the causes for failure. Conclusion: With or without training, the success rate for administering NG was 90.6%, whereas it was only 7.9% for IG. NG was easily and quickly administered even by untrained users, whereas training was necessary for successful administration of IG. NG may expand the community of caregivers who can help PWD during an SH episode. Abbreviations: IG = injectable glucagon; NG = nasal glucagon; PWD = person with diabetes; SH = severe hypoglycemia; T1D = type 1 diabetes; T2D = type 2 diabetes.

GLUCAGON PRESCRIPTION PATTERNS IN PATIENTS WITH EITHER TYPE 1 OR 2 DIABETES WITH NEWLY PRESCRIBED INSULIN.

OBJECTIVE: To describe glucagon prescription patterns in patients with type 1 (T1DM) or type 2 diabetes (T2DM) who received an initial insulin prescription. METHODS: Retrospective analyses were conducted with data from Truven Health MarketScan databases to assess time to glucagon prescriptions: filled within 1.5 months after index date (early) or after 1.5 months postindex (nonearly). The index date was the date of first insulin prescription between January 1, 2009 and December 31, 2011; for T2DM, without an insulin prescription in the previous 6 months; for T1DM, diabetes diagnosis preindex or within 3 months postindex. RESULTS: Analysis included 8,814 patients with T1DM and 47,051 with T2DM (49.3% and 2.4%, respectively) who had glucagon prescriptions filled. The median times to first glucagon prescription were 196 days (T1DM) and 288 days (T2DM). The rates of filling glucagon were highest in the first 1.5 months. The times to first hypoglycemia-related emergency room (ER) visit for T1DM and T2DM cohorts were initially similar for those with early glucagon versus nonearly glucagon prescriptions. After 10.8 and 2.5 months postindex, respectively, the percentage of hypoglycemia-related ER visits was lower for those with early glucagon prescriptions. CONCLUSION: Glucagon prescriptions filled for patients with diabetes who are initiating insulin are low. Patients with T1DM who were younger and healthier filled glucagon prescriptions more often; patients with T2DM who were younger and sicker and had a higher percentage of hypoglycemia-related ER visit history filled glucagon prescriptions more often. Glucagon filled early was associated with a lower incidence of hypoglycemia-related ER visits.

TWO TREATMENT APPROACHES FOR HUMAN REGULAR U-500 INSULIN IN PATIENTS WITH TYPE 2 DIABETES NOT ACHIEVING ADEQUATE GLYCEMIC CONTROL ON HIGH-DOSE U-100 INSULIN THERAPY WITH OR WITHOUT ORAL AGENTS: A RANDOMIZED, TITRATION-TO-TARGET CLINICAL TRIAL.

OBJECTIVE: To compare the efficacy and safety of 2 dosing regimens for human regular U-500 insulin (U-500R, 500 units/mL) replacing high-dose U-100 insulins with or without oral antihyperglycemic drugs in patients with inadequately controlled type 2 diabetes (T2D). METHODS: We conducted a 24-week, open-label, parallel trial in 325 patients (demographics [means]: age, 55.4 years; diabetes duration, 15.2 years; body mass index, 41.9 kg/m(2); glycated hemoglobin [HbA1c], 8.7%; U-100 insulin dose, 287.5 units administered in 5 injections/day [median; range, 2 to 10]). Patients were randomized to thrice-daily (TID, n = 162) or twice-daily (BID, n = 163) U-500R after a 4-week lead-in period. The primary outcome was HbA1c change from baseline. RESULTS: After 24 weeks, both treatments demonstrated significant HbA1c reductions (TID, -1.12%; BID, -1.22%; both, P<.001) and clinical equivalence (difference, -0.10%; 95% confidence interval, -0.33 to 0.12%; noninferiority margin, 0.4%). Comparable increases in total daily U-500R dose (TID, 242.7 to 343.1 units; BID, 249.0 to 335.0 units) were observed. Incidence and rate of documented symptomatic hypoglycemia (≤70 mg/dL) were lower for TID versus BID (P = .003 and P = .02, respectively); severe hypoglycemia was similar between treatments. Weight gain was similar in both groups (TID, 5.4 kg; BID, 4.9 kg). CONCLUSION: Initiation and titration of U-500R using either algorithm (TID or BID) improves glycemic control effectively and safely with fewer injections in patients with T2D treated with high-dose/high-volume U-100 insulin. These results provide clinicians with a practical framework for using U-500R in severely insulin-resistant patients with suboptimally controlled T2D.