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

NCT03844789 | Completed Results DMC FDA Device

• 1 other identifier: DCLP5
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 4

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas (AP); Control-IQ System; Insulin Pump; Closed Loop Control (CLC); Continuous Glucose Monitor (CGM); Multiple Daily Injections (MDI); Sensor Augmented Pump (SAP)

Outcome Measures

Primary Outcomes (1)

• Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period

  The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome.

  From randomization to data collection completion at the end of 16 weeks

Secondary Outcomes (14)

• CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period

  From randomization to data collection completion at the end of 16 weeks

• CGM-Measured Mean Glucose Over 16 Week Trial Period

  From randomization to data collection completion at the end of 16 weeks

• Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period

  At data collection completion at the end of 16 weeks

• CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period

  From randomization to data collection completion at the end of 16 weeks

• CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period

  From randomization to data collection completion at the end of 16 weeks

Other Outcomes (45)

• CGM-Measured Percent of Time in Range 70-140 mg/dL Over 16 Weeks

  From randomization to data collection completion at the end of 16 weeks

• Glucose Variability Measured With the Standard Deviation (SD) Over 16 Weeks

  From randomization to data collection completion at the end of 16 weeks

• CGM-Measured Percent of Time Below 60 mg/dL Over 16 Weeks

  From randomization to data collection completion at the end of 16 weeks

Study Arms (2)

Closed Loop Control (CLC)

EXPERIMENTAL

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 Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. 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

Control Group

ACTIVE COMPARATOR

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 Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.

Device: Control Group

Interventions

t:slim X2 with Control-IQ Technology & Dexcom G6 CGM DEVICE

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

Also known as: Experimental

Closed Loop Control (CLC)

Control Group DEVICE

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.

Also known as: Sensor-Augmented Pump (SAP)

Control Group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 6 months
• Familiarity and use of a carbohydrate ratio for meal boluses.
• Age ≥ 6 and ≤ 13 years old
• Weight ≥25 kg and ≤140 kg
• 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.
• Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
• 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
• Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
• 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 SAP 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 SAP during the extension phase when transition to Control IQ
• Total daily insulin dose (TDD) at least 10 U/day
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
• Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.

You may not qualify if:

• 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).
• 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 (specified on the study procedure manual)
• 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., 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

Sponsors & Collaborators

• University of Virginia: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator
• Jaeb Center for Health Research: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94304, United States

Location

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

UVA Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (7)

• Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Chernavvsky D, Wadwa RP; iDCL Trial Research Group. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med. 2020 Aug 27;383(9):836-845. doi: 10.1056/NEJMoa2004736.

  PMID: 32846062 RESULT

• Kanapka LG, Wadwa RP, Breton MD, Ruedy KJ, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer MJ, Jost E, Carria L, Emory E, Hsu LJ, Weinzimer SA, DeBoer MD, Buckingham BA, Oliveri M, Kollman C, Dokken BB, Chernavvsky D, Beck RW; iDCL Trial Research Group. Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):473-478. doi: 10.2337/dc20-1729. Epub 2020 Dec 21.

  PMID: 33355258 RESULT

• Schoelwer MJ, Kanapka LG, Wadwa RP, Breton MD, Ruedy KJ, Ekhlaspour L, Forlenza GP, Cobry EC, Messer LH, Cengiz E, Jost E, Carria L, Emory E, Hsu LJ, Weinzimer SA, Buckingham BA, Lal RA, Oliveri MC, Kollman CC, Dokken BB, Chernavvsky DR, Beck RW, DeBoer MD; iDCL Trial Research Group. Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System. Diabetes Technol Ther. 2021 Jul;23(7):475-481. doi: 10.1089/dia.2020.0646. Epub 2021 Mar 9.

  PMID: 33689454 RESULT

• Beck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12.

  PMID: 37067353 DERIVED

• Cobry EC, Bisio A, Wadwa RP, Breton MD. Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System. Diabetes Care. 2022 May 1;45(5):1292-1295. doi: 10.2337/dc21-1778.

  PMID: 35202468 DERIVED

• Schoelwer MJ, Bisio A, Breton MD, DeBoer MD. Assessment for Predictors of Rise in Hemoglobin A1c During Extended Use of a Closed-Loop Control System. Diabetes Technol Ther. 2022 Apr;24(4):285-288. doi: 10.1089/dia.2021.0405.

  PMID: 34962164 DERIVED

• Cobry EC, Kanapka LG, Cengiz E, Carria L, Ekhlaspour L, Buckingham BA, Hood KK, Hsu LJ, Messer LH, Schoelwer MJ, Emory E, Ruedy KJ, Beck RW, Wadwa RP, Gonder-Frederick L; iDCL Trial Research Group. Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control. Diabetes Technol Ther. 2021 Jun;23(6):401-409. doi: 10.1089/dia.2020.0532. Epub 2021 Jan 28.

  PMID: 33404325 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

Baseline Measures Overview - Missing data (CLC/SAP): annual household income 4 (5%)/2 (9%), TDI 1 (1%)/0 (0%). Very little missing CGM data: one participant was missing baseline data; another participant was missing follow-up data. Both participants were included in the model for the timepoint with available data so each had one record in the dataset instead of two. This direct likelihood method therefore maximizes the likelihood function integrated over possible values of the missing data.

Results Point of Contact

• Title: Marc Breton
• Organization: University of Virginia Center for Diabetes Technology

mb6nt@virginia.edu

434-982-6484

Study Officials

• Melissa J Schoelwer, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: June 6, 2019
• Primary Completion: December 20, 2019
• Study Completion: March 20, 2020
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (4)