Eyal Dassau1,2, Eric Renard3,4, Jérôme Place4, Anne Farret3,4, Marie-José Pelletier3, Justin Lee2, Lauren M Huyett2, Ankush Chakrabarty1, Francis J Doyle1,2, Howard C Zisser2. 1. Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts. 2. Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, California. 3. Department of Endocrinology, Diabetes, Nutrition and INSERM Clinical Investigation Center 1411, University Hospital of Montpellier, Montpellier, France. 4. Department of Psychology, Institute of Functional Genomics, CNRS UMR5203, INSERM U1191, University of Montpellier, Montpellier, France.
Abstract
AIMS: To compare intraperitoneal (IP) to subcutaneous (SC) insulin delivery in an artificial pancreas (AP). RESEARCH DESIGN AND METHODS: Ten adults with type 1 diabetes participated in a non-randomized, non-blinded sequential AP study using the same SC glucose sensing and Zone Model Predictive Control (ZMPC) algorithm adjusted for insulin clearance. On first admission, subjects underwent closed-loop control with SC delivery of a fast-acting insulin analogue for 24 hours. Following implantation of a DiaPort IP insulin delivery system, the identical 24-hour trial was performed with IP regular insulin delivery. The clinical protocol included 3 unannounced meals with 70, 40 and 70 g carbohydrate, respectively. Primary endpoint was time spent with blood glucose (BG) in the range of 80 to 140 mg/dL (4.4-7.7 mmol/L). RESULTS: Percent of time spent within the 80 to 140 mg/dL range was significantly higher for IP delivery than for SC delivery: 39.8 ± 7.6 vs 25.6 ± 13.1 ( P = .03). Mean BG (mg/dL) and percent of time spent within the broader 70 to 180 mg/dL range were also significantly better for IP insulin: 151.0 ± 11.0 vs 190.0 ± 31.0 ( P = .004) and 65.7 ± 9.2 vs 43.9 ± 14.7 ( P = .001), respectively. Superiority of glucose control with IP insulin came from the reduced time spent in hyperglycaemia (>180 mg/dL: 32.4 ± 8.9 vs 53.5 ± 17.4, P = .014; >250 mg/dL: 5.9 ± 5.6 vs 23.0 ± 11.3, P = .0004). Higher daily doses of insulin (IU) were delivered with the IP route (43.7 ± 0.1 vs 32.3 ± 0.1, P < .001) with no increased percent time spent <70 mg/dL (IP: 2.5 ± 2.9 vs SC: 4.1 ± 5.3, P = .42). CONCLUSIONS: Glycaemic regulation with fully-automated AP delivering IP insulin was superior to that with SC insulin delivery. This pilot study provides proof-of-concept for an AP system combining a ZMPC algorithm with IP insulin delivery.
AIMS: To compare intraperitoneal (IP) to subcutaneous (SC) insulin delivery in an artificial pancreas (AP). RESEARCH DESIGN AND METHODS: Ten adults with type 1 diabetes participated in a non-randomized, non-blinded sequential AP study using the same SC glucose sensing and Zone Model Predictive Control (ZMPC) algorithm adjusted for insulin clearance. On first admission, subjects underwent closed-loop control with SC delivery of a fast-acting insulin analogue for 24 hours. Following implantation of a DiaPort IP insulin delivery system, the identical 24-hour trial was performed with IP regular insulin delivery. The clinical protocol included 3 unannounced meals with 70, 40 and 70 g carbohydrate, respectively. Primary endpoint was time spent with blood glucose (BG) in the range of 80 to 140 mg/dL (4.4-7.7 mmol/L). RESULTS: Percent of time spent within the 80 to 140 mg/dL range was significantly higher for IP delivery than for SC delivery: 39.8 ± 7.6 vs 25.6 ± 13.1 ( P = .03). Mean BG (mg/dL) and percent of time spent within the broader 70 to 180 mg/dL range were also significantly better for IP insulin: 151.0 ± 11.0 vs 190.0 ± 31.0 ( P = .004) and 65.7 ± 9.2 vs 43.9 ± 14.7 ( P = .001), respectively. Superiority of glucose control with IP insulin came from the reduced time spent in hyperglycaemia (>180 mg/dL: 32.4 ± 8.9 vs 53.5 ± 17.4, P = .014; >250 mg/dL: 5.9 ± 5.6 vs 23.0 ± 11.3, P = .0004). Higher daily doses of insulin (IU) were delivered with the IP route (43.7 ± 0.1 vs 32.3 ± 0.1, P < .001) with no increased percent time spent <70 mg/dL (IP: 2.5 ± 2.9 vs SC: 4.1 ± 5.3, P = .42). CONCLUSIONS: Glycaemic regulation with fully-automated AP delivering IP insulin was superior to that with SC insulin delivery. This pilot study provides proof-of-concept for an AP system combining a ZMPC algorithm with IP insulin delivery.
Authors: Trang T Ly; Anirban Roy; Benyamin Grosman; John Shin; Alex Campbell; Salman Monirabbasi; Bradley Liang; Rie von Eyben; Satya Shanmugham; Paula Clinton; Bruce A Buckingham Journal: Diabetes Care Date: 2015-06-06 Impact factor: 19.112
Authors: N Jeandidier; J L Selam; E Renard; B Guerci; V Lassman-Vague; L Rocher; H Hanaire-Broutin Journal: Diabetes Care Date: 1996-07 Impact factor: 19.112
Authors: Daniel A Finan; Eyal Dassau; Marc D Breton; Stephen D Patek; Thomas W McCann; Boris P Kovatchev; Francis J Doyle; Brian L Levy; Ramakrishna Venugopalan Journal: J Diabetes Sci Technol Date: 2015-06-30
Authors: Peter R van Dijk; Susan J J Logtenberg; Simona I Chisalita; Christina A Hedman; Klaas H Groenier; Reinold O B Gans; Nanne Kleefstra; Hans J Arnqvist; Henk J G Bilo Journal: Growth Horm IGF Res Date: 2015-08-28 Impact factor: 2.372
Authors: Ankush Chakrabarty; Justin M Gregory; L Merkle Moore; Philip E Williams; Ben Farmer; Alan D Cherrington; Peter Lord; Brian Shelton; Don Cohen; Howard C Zisser; Francis J Doyle; Eyal Dassau Journal: J Process Control Date: 2019-02-23 Impact factor: 3.666
Authors: John H Abel; Marcus A Badgeley; Taylor E Baum; Sourish Chakravarty; Patrick L Purdon; Emery N Brown Journal: Proc IFAC World Congress Date: 2021-04-14