A Study of t:Slim X2 With Control-IQ Technology (DCLP5)

• Sponsor: University of Virginia
• Collaborators: Tandem Diabetes Care, Inc.; DexCom, Inc.; Jaeb Center for Health Research
• Information provided by (Responsible Party): University of Virginia

Study Description

Brief Summary:

The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes Mellitus	Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM; Device: Standard of Care	Not Applicable

Detailed Description:

After consent is signed, eligibility will be assessed. Eligible participants not currently using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in phase of 2-4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. Standard of Care (SC) for 16 weeks. The Standard of Care (SC) group will be offered to transition to use CLC and the experimental arm will extend their use of CLC for 12 weeks.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology
• Actual Study Start Date: June 6, 2019
• Estimated Primary Completion Date: March 1, 2020
• Estimated Study Completion Date: March 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Closed Loop Control (CLC); Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology & Dexcom G6 CGM vs Standard of Care (SC) for 4 months. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 4 months. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.	Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM; Eligible participants will be use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology & Dexcom G6 CGM; Other Name: Experimental
Active Comparator: Standard of Care (SC); Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC) for 4 months. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.	Device: Standard of Care; Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.; Other Name: Control

Outcome Measures

Primary Outcome Measures :

1. Target in range in main study [ Time Frame: 4 months ]
   The primary outcome for the first phase is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SC) group
2. Target in range in extension study [ Time Frame: 3 months ]
   The primary outcome for the extension phase is improving time in range 70-180 mg/dL by CGM when SC (control group) transitions to t:slim X2 with Control-IQ compared with the same group during the Main Phase.

Secondary Outcome Measures :

1. CGM-measured % above 180 mg/dL [ Time Frame: 7 months ]
   Percent
2. GM-measured mean glucose [ Time Frame: 7 months ]
   mg/dL
3. HbA1c at 16 weeks [ Time Frame: 7 months ]
   Percent
4. CGM-measured % below 70 mg/dL [ Time Frame: 7 months ]
   Percent
5. CGM-measured % below 54 mg/dL [ Time Frame: 7 months ]
   Percent

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 13 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 6 months
2. Familiarity and use of a carbohydrate ratio for meal boluses.
3. Age ≥ 6 and ≤ 13 years old
4. 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 serum or 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.
5. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
6. Willingness to suspend use of any personal closed loop system that they use at home for the duration of the clinical trial once the study CGM is in use
7. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol

8. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using to t:slim X2. This includes:

   • Participants randomized to Control IQ
   • Participants on the SC group on MDI treatment that will be provided a Tandem pump to switch to CSII
   • Participates that are already in Continuous Subcutaneous Insulin Infusion (CSII) randomized to SC during the extension phase when transition to Control IQ
9. Total daily insulin dose (TDD) at least 10 U/day
10. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
11. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.

Exclusion Criteria:

1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including glucagon-like peptide [GLP-1] agonists, Symlin, dipeptidyl peptidase 4 [DPP-4] inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, sulfonylureas).
2. Hemophilia or any other bleeding disorder
3. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified on the study procedure manual)
4. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
5. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., 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

Contacts and Locations

Contacts

Contact: Jess L Robic, BS; 434-982-3459; jlr8yq@virginia.edu

Contact: Emma G Emory, RN; 434-243-3992; ee9m@virginia.edu

Locations

United States, California

Stanford University; Recruiting

Stanford, California, United States, 94304

Contact: Bruce Buckingham, MD 650-723-5791 bbendo@stanford.edu

Contact: Marissa A. Town, RN, BSN, CDE 650-736-6660 marissah@stanford.edu

United States, Colorado

Barbara Davis Center, University of Colorado; Recruiting

Aurora, Colorado, United States, 80045

Contact: R. Paul Wadwa, MD 303-724-2323 paul.wadwa@ucdenver.edu

Contact: Emily Jost, MPH RD CDE 303-724-7313 emily.jost@ucdenver.edu

Principal Investigator: R. Paul Wadwa, MD

United States, Connecticut

Yale University; Recruiting

New Haven, Connecticut, United States, 06511

Contact: Eda Cengiz, MD,MHS,FAAP eda.cengiz@yale.edu

Contact: Lori Carria, MS 203-737-3595 lori.carria@yale.edu

United States, Virginia

UVA Center for Diabetes Technology; Recruiting

Charlottesville, Virginia, United States, 22903

Contact: Melissa J Schoelwer, MD mjs3pg@virginia.edu

Sub-Investigator: Marc D. Breton, PhD

Sponsors and Collaborators

University of Virginia

Tandem Diabetes Care, Inc.

DexCom, Inc.

Jaeb Center for Health Research

Investigators

• Principal Investigator: Melissa J Schoelwer, MD; University of Virginia

More Information

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT03844789 History of Changes
• Other Study ID Numbers: DCLP5
• First Posted: February 18, 2019
• Last Update Posted: June 18, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• 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.

• 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
• Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Virginia:

Artificial Pancreas (AP); Control-IQ System; Insulin Pump; Closed Loop Control (CLC); Continuous Glucose Monitor (CGM); Standard of Care (SC); Multiple Daily Injections (MDI)

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs