In adults with long-standing type 1 diabetes experiencing mild to moderate hypoglycemia, treatment with a “mini-dose” of ready-to-use, subcutaneous glucagon is a safe, effective alternative to treatment with oral carbohydrates, according to findings from a randomized crossover study.
“Many individuals with type 1 diabetes, particularly those under tight metabolic control, experience mild hypoglycemia on a daily or near-daily basis for which treatment consists of oral carbohydrate and is generally successful,” Morey W. Haymond, MD, professor of medicine and pediatrics at Baylor College of Medicine in Houston, and colleagues wrote. “However, carbohydrate treatment often results in hyperglycemia, prompting additional insulin administration, which can result in more hypoglycemia. Thus, regaining glycemic control may take hours.”
Haymond and colleagues analyzed data from 16 participants with type 1 diabetes recruited from five centers within the T1D Exchange Clinic Network with an investigational new drug approval from the FDA (mean age, 39 years; 75% women; mean diabetes duration, 23 years; mean HbA1c, 7.2%). Included participants used a continuous glucose monitor, insulin pump therapy (with no use of active low-glucose suspend feature) and experienced at least three blood glucose readings of less than 70 mg/dL over 2 weeks, measured via CGM. During two randomly assigned, 3-week periods, participants used either a mini-dose glucagon injection (G-Pen Mini, Xeris Pharmaceuticals) or oral glucose tablets (Dex4) when experiencing a blood glucose between 50 mg/dL and 69 mg/dL. Treatment was 150 µg glucagon or 16 g glucose tabs, depending on study period; treatment was doubled when participants experienced a blood glucose reading between 40 mg/dL and 49 mg/dL. Blood glucose was re-checked via a glucose meter 15 minutes after self-administering the dose. Information on hypoglycemia (symptoms, causes and treatment) was entered by participants in real-time using the Glooko platform via smartphone, using the Joslin HypoMap mobile app customized for the study. Successful treatment was defined as a blood glucose of at least 50 mg/dL 15 minutes after treatment and at least 70 mg/dL 30 minutes after intervention.
During the study, there was 118 analyzable events with an initial blood glucose between 50 mg/dL and 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the mini-dose glucagon period and for 53 (95%) of 56 events during the glucose tabs period (adjusted P = .99). Clinical assessments of success for these events were 97% during the mini-dose glucagon period and 96% during the glucose tabs period.
There were no between-group differences for CGM-measured time-in-range of 70 mg/dL to 180 mg/dL during the 2 hours after hypoglycemic events, but treatment with glucose tablets resulted in a higher maximum glucose (116 mg/dL vs. 102 mg/dL; P = .01) over the first hour, according to the researchers.
In a free-text field inquiring about likes and dislikes of the glucagon pen, researchers noted several recurring comments from participants, including notes about injection-site discomfort, dislike of giving injections in public and noting that, unlike carbohydrate consumption, glucagon did not cause a spike in blood glucose. – by Regina Schaffer
Disclosure: Xeris Pharmaceuticals Inc. provided the glucagon injections for this study. The researchers report no relevant financial disclosures.