15-LB: Ready-to-Use Glucagon for the Prevention of Exercise-Induced Hypoglycemia during Aerobic Exercise
Bibliographic record
Abstract
Objective: A novel ready-to-use liquid stable glucagon (RTUG; Xeris Pharmaceuticals) was evaluated for safety and efficacy in the prevention of exercise induced hypoglycemia (EIH) during and after moderate-to-high intensity aerobic exercise. Method: A Phase 2 randomized, placebo-controlled, double-blind, clinical research center (CRC) crossover stage, followed by a 12-week 3-arm parallel Outpatient stage, enrolled 48 adults with type 1 diabetes using an insulin pump. In the outpatient stage, subjects were assigned to RTUG 150 μg plus 50% basal insulin pump reduction, or RTUG 150 μg with no insulin change, or to placebo. Blood glucose was measured by blood glucose meter before, during, and after moderate-to-high intensity, aerobic exercise to evaluate the incidence and severity of hypoglycemia. Continuous glucose monitors were utilized in the CRC and Outpatient stage. Result: Of the 48 subjects, 45 subjects (93.8%) completed multiple exercise sessions and have entered the ongoing outpatient stage. On average, subjects were 37 (±11.2) years old with an average BMI of 26.7 (±4.6), 52.1% male and 81.3% white. In the CRC stage, the placebo group experienced more EIH (16.7% vs. 2.1%), had 7-times higher glucose tablet utilization during and after exercise, resulting in more post-exercise hyperglycemia (blood glucose >250 mg/dL). To date, no SAEs have occurred, and RTUG 150 μg caused no edema, erythema, nor injection site reactions. Conclusion: RTUG 150 μg maintained euglycemia during prolonged, continuous, intense aerobic exercise. In the CRC stage, RTUG was more effective than insulin reduction alone, to prevent EIH, and may result in less post-exercise hyperglycemia than ingestion of carbohydrate. Data from the ongoing Outpatient stage may support the use of RTUG to prevent EIH during and after aerobic exercise in real-world settings. Disclosure R. Aronson: Consultant; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Gilead Sciences, Inc., HTL Strefa, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Research Support; Self; AstraZeneca, Bausch Health, Bayer Inc., Becton, Dickinson and Company, Boehringer Ingelheim (Canada) Ltd., Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Kowa Company, Ltd., Medpace, Novo Nordisk Inc., Sanofi, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. M. Riddell: Advisory Panel; Self; Zucara Therapeutics Inc. Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc., Insulet Corporation. Speaker’s Bureau; Self; Medtronic, Novo Nordisk A/S. M.K. Junaidi: Employee; Self; Xeris Pharmaceuticals, Inc. N.C. Close: Employee; Self; EmpiriStat, Inc. D.J. Sequeira: Employee; Self; Xeris Pharmaceuticals, Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".