Cited by 32Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes and associated disorders

Effect of Afrezza on Glucose Dynamics During HCL Treatment

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Galderisi, Alfonso, Cohen, Nathan, Calhoun, Peter, Kraemer, Kristen, Breton, Marc, Weinzimer, Stuart, Cengiz, Eda·2020·Diabetes Care

Abstract

OBJECTIVE: A major obstacle in optimizing the performance of closed-loop automated insulin delivery systems has been the delay in insulin absorption and action that results from the subcutaneous (SC) route of insulin delivery leading to exaggerated postmeal hyperglycemic excursions. We aimed to investigate the effect of Afrezza inhaled insulin with ultrafast-in and -out action profile on improving postprandial blood glucose control during hybrid closed-loop (HCL) treatment in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (AL) and a high (AH) dose as compared with a standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for AH and down for AL). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to 4 h after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics. RESULTS: The mean ± SD PPG for the rapid-acting insulin control arm and AH was similar (185 ± 50 mg/dL vs. 195 ± 46 mg/dL, respectively; P = 0.45), while it was higher for meals using AL (208 ± 54 mg/dL, P = 0.04). The AH achieved significantly lower early PPG level than the control arm (30 min; P < 0.001), and improvement in PPG waned at later time points (120 and 180 min; P = 0.02) coinciding with the end of Afrezza glucodynamic action. CONCLUSIONS: Afrezza (AH) premeal bolus reduced the early glycemic excursion and improved PPG during HCL compared with aspart premeal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120 min.

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  • Alternative routes of insulin delivery, such as intraperitoneal insulin and the addition of premeal inhaled insulin (Afrezza) to AID systems, are being investigated.

    “Alternative routes of insulin delivery, such as intraperitoneal insulin and the addition of premeal inhaled insulin (Afrezza) to AID systems, are being investigated.106”

    From The future of type 1 diabetes therapy (2025) · cites this paper as [106]

    The Objective and Research Design and Methods sections describe a study of premeal inhaled Afrezza during hybrid closed-loop insulin delivery. The passages provide no support for the intraperitoneal-insulin example; a search for that term found no relevant passage. Page numbers were not available in our copy. (LLM, conf=0.85)

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References 28 · Cited by 32

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Authors
Galderisi, A., Cohen, N., Calhoun, P., Kraemer, K., Breton, M., Weinzimer, S., & Cengiz, E.
Affiliations
  • University of Padua (IT)
  • Jaeb Center for Health Research (US)
  • Yale University (US)
  • University of Virginia (US)
  • Bahçeşehir University (TR)
Corresponding author
Galderisi, Alfonso
Venue
Diabetes Care
Published
2020-07-13
Volume
43
Issue
9
Pages
2146-2152
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
OpenAlex
W3043371052
Cited by
32
References
28
Citations by year
2026: 4 · 2025: 9 · 2024: 5 · 2023: 5 · 2022: 5 · 2021: 4
FWCI
2.64
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Padua Research Archive (University of Padova) (submittedVersion)
Funders
  • JDRF (2-APF-2019-737-A-N, JDRF 3-SRA-2016-244-M-R)
  • National Institutes of Health (1DP3DK106826-01)
  • National Center for Research Resources
  • National Center for Advancing Translational Science (UL1 RR024139)
  • International Society for Pediatric and Adolescent Diabetes (Fellowship 2016)
  • Robert E. Leet and Clara Guthrie Patterson Trust
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
Afrezza, inhaled insulin, type 1 diabetes, hybrid closed-loop insulin delivery, postprandial blood glucose, rapid-acting insulin, insulin absorption, insulin-to-carbohydrate ratio, glycemic excursions, hypoglycemia, hyperglycemia
MeSH terms
Glycemic Control, Administration, Inhalation, Adolescent, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Dose-Response Relationship, Drug, Equipment and Supplies, Female, Humans, Hypoglycemic Agents, Insulin Infusion Systems, Male, Blood Glucose Self-Monitoring, Cross-Over Studies, Postprandial Period, Young Adult, Insulin, Regular, Human, Meals

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