A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)

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Status and phase

Completed
Phase 1

Conditions

Type1 Diabetes Mellitus

Treatments

Drug: Insulin Lispro
Device: AID System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03367390
16679
F3Z-MC-IOQS (Other Identifier)

Details and patient eligibility

About

The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to. This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants with T1DM for at least 2 years and who have used an insulin delivery system for at least 1 year
  • Have a body mass index of 18.5 to 35 kilogram per meter squared
  • Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion criteria

  • Have known allergies or history of hypersensitivity to insulin lispro
  • Have had an episode of severe hypoglycemia within the past 6 months
  • Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

AID System Containing Insulin Lispro
Experimental group
Description:
The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component.
Treatment:
Device: AID System
Drug: Insulin Lispro

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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