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A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03848767
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 19, 2019
First Posted Date  ICMJE February 21, 2019
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE February 20, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • Number of Adverse Events (AEs) [ Time Frame: In-Patient Period (3 Days) ]
    Number of AEs
  • Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL [ Time Frame: In-Patient Period (3 Days) ]
    CGM measured percentage of time <70 milligrams per deciliter (mg/dL)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03848767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges
Official Title  ICMJE An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus During Meal Challenges
Brief 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 during meal challenges.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Device: AID System
    AID System
    Other Name: LY8888AU
  • Drug: Insulin Lispro
    Individualized doses of insulin lispro administered via the AID system to maintain glycemic control except during meal challenges.
    Other Name: LY275585
Study Arms  ICMJE 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.
Interventions:
  • Device: AID System
  • Drug: Insulin Lispro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
  • Have a body mass index of 18.5 to 37 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03848767
Other Study ID Numbers  ICMJE 17177
F3Z-MC-IORD ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP