The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
An Extension Study of t:Slim X2 With Control-IQ Technology
2 other identifiers
interventional
164
1 country
7
Brief Summary
This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedStudy Start
First participant enrolled
January 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2020
CompletedResults Posted
Study results publicly available
August 25, 2022
CompletedAugust 31, 2022
August 1, 2022
1.1 years
June 19, 2018
February 28, 2021
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in Target Range
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
13 weeks
Secondary Outcomes (36)
CGM Time Above 180
13 weeks
CGM Mean Glucose
13 weeks
CGM Time Below 70
13 weeks
CGM Time Below 54
13 weeks
CGM Time in Range 70-140 mg/dL
13 weeks
- +31 more secondary outcomes
Other Outcomes (36)
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
13 weeks
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
13 weeks
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
13 weeks
- +33 more other outcomes
Study Arms (2)
Closed Loop Control (CLC)
EXPERIMENTALParticipants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 Continuous Glucose Monitor (CGM) for 3 months. Objective 1: This arm is participants who had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial) Objective 2: This arm is participants who had 6 months of sensor-augmented pump (SAP) in the primary trial (DCLP3 Pivotal Trial) Objective 3: This arm is participants who had 3 months of CLC in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology \& Dexcom G6 CGM until the product is commercially available.
Predictive-Low Glucose Suspend (PLGS)
ACTIVE COMPARATORParticipants randomized to Predictive-Low Glucose Suspend (PLGS) will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Objective 1: This arm is participants who had 6 months of PLGS in the primary trial (DCLP3 Pivotal Trial) Objective 2: This arm is not applicable to objective 2 Objective 3: This arm is participants who had 3 months of PLGS in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology \& Dexcom G6 CGM until the product is commercially available.
Interventions
Participants will use the Tandem t:slim X2 insulin pump with Control-IQ Technology \& Dexcom G6 CGM for 3 months.
Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.
Eligibility Criteria
You may qualify if:
- Successful completion of the original 6-month RCT within the prior 14 days
- For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
- Willingness to not use a personal CGM for the duration of the study
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
You may not qualify if:
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Dexcom, Inc., or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Jaeb Center for Health Researchcollaborator
- Tandem Diabetes Care, Inc.collaborator
- DexCom, Inc.collaborator
- Roche Diagnostics GmbHcollaborator
Study Sites (7)
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Stanford University
Stanford, California, 94304, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045, United States
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
Related Publications (1)
Levy CJ, O'Malley G, Raghinaru D, Kudva YC, Laffel LM, Pinsker JE, Lum JW, Brown SA; iDCL Trial Research Group. Insulin Delivery and Glucose Variability Throughout the Menstrual Cycle on Closed Loop Control for Women with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):357-361. doi: 10.1089/dia.2021.0431. Epub 2022 Feb 21.
PMID: 35099294DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sue Brown, MD
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Sue Brown, MD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2018
First Posted
July 19, 2018
Study Start
January 17, 2019
Primary Completion
February 28, 2020
Study Completion
March 9, 2020
Last Updated
August 31, 2022
Results First Posted
August 25, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Generally, data will be made available after the primary publications of each study.
- Access Criteria
- The Data Sharing Agreements will be formulated by the Steering Committee in collaboration with the NIH Project Scientist Program Official. In addition, under special arrangements, complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "...generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems in the target population of people with type 1 diabetes."
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.