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

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ClinicalTrials.gov Identifier: NCT03849612
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: AID System Drug: Insulin Lispro Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : March 21, 2019
Estimated Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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
AID system
Other Name: LY8888AU

Drug: Insulin Lispro
Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other Name: LY275585




Primary Outcome Measures :
  1. Number of Adverse Events (AEs) [ Time Frame: In-Patient Period (5 Days) ]
    Number of AEs

  2. Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL [ Time Frame: In-Patient Period (5 Days) ]
    CGM measured percentage of time <70 milligrams per deciliter (mg/dL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849612


Contacts
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Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
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United States, California
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Principal Investigator: Mark P Christiansen         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03849612     History of Changes
Other Study ID Numbers: 17175
F3Z-MC-IORB ( Other Identifier: Eli Lilly and Company )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs