A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
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|ClinicalTrials.gov Identifier: NCT03367390|
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : March 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type1 Diabetes Mellitus||Device: AID System Drug: Insulin Lispro||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus|
|Actual Study Start Date :||November 8, 2017|
|Actual Primary Completion Date :||February 9, 2018|
|Actual Study Completion Date :||February 9, 2018|
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
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
- 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 ]
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): NCT03367390
|United States, Washington|
|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, United States, 98057|
|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|