Intraperitoneal insulin delivery provides superior glycaemic regulation to subcutaneous insulin delivery in model predictive control-based fully-automated artificial pancreas in patients with type 1 diabetes: a pilot study

Diabetes Obes Metab. 2017 Dec;19(12):1698-1705. doi: 10.1111/dom.12999. Epub 2017 Jul 6.

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.

Keywords: CGM; CSII; DiaPort; artificial pancreas; closed-loop; hyperglycaemia; hypoglycaemia intraperitoneal; insulin pump; model predictive control; type 1 diabetes.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Algorithms
  • Blood Glucose / analysis
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / therapy*
  • Female
  • France
  • Glycated Hemoglobin / analysis
  • Humans
  • Hyperglycemia / prevention & control*
  • Hypoglycemia / chemically induced
  • Hypoglycemia / prevention & control*
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use
  • Infusions, Parenteral
  • Infusions, Subcutaneous
  • Insulin Infusion Systems* / adverse effects
  • Insulin Lispro / administration & dosage*
  • Insulin Lispro / adverse effects
  • Insulin Lispro / therapeutic use
  • Insulin, Regular, Human / administration & dosage
  • Insulin, Regular, Human / adverse effects
  • Insulin, Regular, Human / therapeutic use
  • Male
  • Middle Aged
  • Pancreas, Artificial* / adverse effects
  • Pilot Projects
  • Proof of Concept Study

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin Lispro
  • Insulin, Regular, Human
  • hemoglobin A1c protein, human