77-OR: First Human Study Testing the iLet, a Purpose-Built Bionic Pancreas Platform
| Autor: | Bruce A. Buckingham, Rabab Z. Jafri, Jordan Sherwood, Rajendranath Selagamsetty, Costik John R, Laya Ekhlaspour, Edward R. Damiano, Mallory A. Hillard, Courtney A. Balliro, Liana Hsu, Jason Sloane, El-Khatib Firas H, Steven Russell |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Insulin pump medicine.medical_specialty business.industry Endocrinology Diabetes and Metabolism Significant difference Bionic Pancreas 030209 endocrinology & metabolism Human study 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Family medicine Usual care Internal Medicine medicine General hospital business |
| Zdroj: | Diabetes. 68 |
| ISSN: | 1939-327X 0012-1797 |
| DOI: | 10.2337/db19-77-or |
| Popis: | The Gen3 iLet (iLet) is a purpose-built, fully integrated, bionic pancreas (BP) platform that can operate in a bihormonal, insulin-only, or glucagon-only mode and can receive data from the Dexcom G5 or the Senseonics Eversense implanted CGM. We performed a random-order, cross-over, outpatient study comparing the insulin-only mode of the iLet to usual care (UC) for 7 days each as a bridge from past studies using the BP algorithm on an iPhone connected wirelessly to an insulin pump. The study enrolled adults with T1D who used either MDI (n=12) or CSII (n=22) for their UC. Participants enrolled at Massachusetts General Hospital (n=17) used the Eversense while those at Stanford (n=17) used the G5 as the input CGM signal for the iLet. There was no statistically significant difference between the iLet and UC in % time Disclosure R.Z. Jafri: None. C.A. Balliro: None. J. Sherwood: None. M. Hillard: None. L. Ekhlaspour: None. L. Hsu: None. R. Selagamsetty: Employee; Self; Beta Bionics. Other Relationship; Self; Boston University. J.R. Costik: Board Member; Self; Nightscout Foundation. Employee; Self; Beta Bionics. Employee; Spouse/Partner; Ortho Clinical Diagnostics. J. Sloane: None. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. F. El-Khatib: Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. E. Damiano: Advisory Panel; Self; Novo Nordisk A/S. Board Member; Self; Beta Bionics. Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. Stock/Shareholder; Spouse/Partner; Beta Bionics. Other Relationship; Self; Ascensia Diabetes Care, Senseonics. S.J. Russell: Advisory Panel; Self; Companion Medical, Unomedical a/s. Consultant; Self; Flexion Therapeutics. Research Support; Self; Beta Bionics, MITRE Corporation, Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Self; ADOCIA, Ascensia Diabetes Care, Ascensia Diabetes Care, Lilly Diabetes, Roche Diabetes Care, Senseonics. Funding National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108612) |
| Databáze: | OpenAIRE |
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