First Look at Control-IQ: A New-Generation Automated Insulin Delivery System

Diabetes Care. 2018 Dec;41(12):2634-2636. doi: 10.2337/dc18-1249. Epub 2018 Oct 10.

Abstract

Objective: To pilot test a new closed-loop control technology to validate it for a further large clinical trial.

Research design and methods: The t:slim X2 insulin pump with Control-IQ Technology (Tandem Diabetes Care) includes a Dexcom G6 sensor and a closed-loop algorithm implemented in the pump that 1) automates insulin correction boluses, 2) has a dedicated hypoglycemia safety system, and 3) gradually intensifies control overnight, aiming for blood glucose levels of approximately 100-120 mg/dL every morning.

Results: Five patients with type 1 diabetes (mean age 52.8 years, 2/3 male/female, mean A1C 6.5%) used Control-IQ in an outpatient setting (hotel) for approximately 37 h. During the closed loop, mean glucose was 129 mg/dL (135/121 mg/dL during the day/night), time within target range 70-180 mg/dL was 87% (82%/94% during the day/night), and time <60 mg/dL was 1.1% (2.0%/0.0% during the day/night).

Conclusions: Following this pilot trial, Control-IQ was deployed in several studies, including the large-scale National Institutes of Health International Diabetes Closed-Loop (iDCL) Trial.

Trial registration: ClinicalTrials.gov NCT03368937.

Publication types

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

MeSH terms

  • Blood Glucose / analysis*
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism
  • Blood Glucose Self-Monitoring / instrumentation
  • Blood Glucose Self-Monitoring / methods
  • Diabetes Mellitus, Type 1 / blood*
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Female
  • Humans
  • Hypoglycemia / blood
  • Hypoglycemia / chemically induced
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Insulin / administration & dosage*
  • Insulin / adverse effects
  • Insulin Infusion Systems*
  • Inventions
  • Male
  • Middle Aged
  • Pilot Projects

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin

Associated data

  • ClinicalTrials.gov/NCT03368937