CompletedNCT03367390Updated Mar 15, 2018

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

A Phase 1 interventional study of AID System and Insulin Lispro in Type1 Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-15.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Device feasibility

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study summary

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.

Conditions studied

Type1 Diabetes Mellitus

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Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
AID System Containing Insulin Lispro
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.
Device: AID System · Drug: Insulin Lispro

Interventions

DeviceAID System
AID system
Also known as: LY8888AU
DrugInsulin Lispro
Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Also known as: LY275585

What researchers measure

Primary outcomes

Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges
Time frame: Up to 4 hours post challenge
Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge
Time frame: Up to 4 hours post challenge
Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity
Time frame: Up to 4 hours post challenge

Study locations

1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Renton, Washington 98057, United States

References and documents

Registry details

Key details

Study ID: NCT03367390
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Dec 8, 2017
Start date: Nov 8, 2017
Primary completion: Feb 9, 2018
Completion: Feb 9, 2018
Last update: Mar 15, 2018

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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