Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: An open-label, randomised, crossover, controlled trial

Diabetes Obes Metab. 2017 May;19(5):713-720. doi: 10.1111/dom.12880. Epub 2017 Mar 8.

Abstract

Aims: To assess whether the dual-hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared to the single-hormone (insulin alone) artificial pancreas in outpatient settings during the day and night.

Material and methods: In a randomized, three-way, crossover trial we compared the dual-hormone artificial pancreas, the single-hormone artificial pancreas and sensor-augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 8 AM Day 1 to 8 PM Day 3 (60 hours) in outpatient free-living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/L. A P value of less than .017 was regarded as significant.

Results: The median difference between the dual-hormone system and the single-hormone system was -2.3% (P = .072) for time spent below 4.0 mmol/L, -1.3% (P = .017) for time below 3.5 mmol/L, and -0.7% (P = .031) for time below 3.3 mmol/L. Both systems reduced (P < .017) hypoglycaemia below 4.0, 3.5 and 3.3 mmol/L compared to control therapy, but reductions were larger with the dual-hormone system than with the single-hormone system (medians -4.0% vs -3.4% for 4.0 mmol/L; -2.7% vs -2.2% for 3.5 mmol/L; and -2.2% vs -1.2% for 3.3 mmol/L). There were 34 hypoglycaemic events (<3.0 mmol/L for 20 minutes) with control therapy, 14 with the single-hormone system and 6 with the dual-hormone system. These differences in hypoglycaemia were observed while mean glucose level was low and comparable in all interventions (P = NS).

Conclusions: The dual-hormone artificial pancreas had the lowest risk of hypoglycaemia, but the differences were not statistically significant. Larger studies are needed.

Keywords: artificial pancreas, closed-loop insulin delivery, glucagon; hypoglycaemia; insulin therapy; randomised trial; type 1 diabetes.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Adult
  • Blood Glucose / analysis
  • Combined Modality Therapy / adverse effects
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / drug therapy
  • Diabetes Mellitus, Type 1 / therapy*
  • Glucagon / administration & dosage
  • Glucagon / adverse effects
  • Glucagon / therapeutic use
  • Glycated Hemoglobin A / analysis
  • Hormone Replacement Therapy / adverse effects
  • Hormone Replacement Therapy / instrumentation*
  • Humans
  • Hyperglycemia / prevention & control*
  • Hypoglycemia / chemically induced
  • Hypoglycemia / epidemiology
  • Hypoglycemia / prevention & control*
  • Infusion Pumps / adverse effects
  • Insulin / administration & dosage
  • Insulin / adverse effects
  • Insulin / therapeutic use
  • Insulin Infusion Systems / adverse effects
  • Middle Aged
  • Monitoring, Ambulatory / instrumentation
  • Pancreas, Artificial* / adverse effects
  • Patient Education as Topic
  • Quebec / epidemiology
  • Risk

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Insulin
  • hemoglobin A1c protein, human
  • Glucagon