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

• ClinicalTrials.gov Identifier: NCT03844789
• Recruitment Status: Completed
• First Posted: February 18, 2019
• Last Update Posted: December 7, 2020
• 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: Control Group	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. Control Group for 16 weeks. The Control 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)
• Actual Enrollment: 101 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
• Actual Primary Completion Date: December 20, 2019
• Actual Study Completion Date: March 20, 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 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; 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: Control Group; 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; 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. Time in range in main study [ Time Frame: 16 weeks ]
   The primary outcome for the first phase is % time in target range 70-180 mg/dL measured by CGM in CLC group vs. Control Group.

Secondary Outcome Measures :

1. CGM-measured % above 180 mg/dL [main study] [ Time Frame: 16 weeks ]
   Percent
2. CGM-measured mean glucose [main study] [ Time Frame: 16 weeks ]
   mg/dL
3. HbA1c at 16 weeks [main study] [ Time Frame: 16 weeks ]
   Percent
4. CGM-measured % below 70 mg/dL [main study] [ Time Frame: 16 weeks ]
   Percent
5. CGM-measured % below 54 mg/dL [main study] [ Time Frame: 16 weeks ]
   Percent
6. CGM-measured % above 250 mg/dL [main study] [ Time Frame: 16 weeks ]
   Percent
7. Glucose variability measured with the coefficient of variation (CV) [main study] [ Time Frame: 16 weeks ]
   Coefficient of variation- CGM measured
8. CGM-measured % above 180 mg/dL [extension study] [ Time Frame: 12 weeks ]
   Percent
9. CGM-measured mean glucose [extension study] [ Time Frame: 12 weeks ]
   mg/dL
10. HbA1c at 28 weeks [extension study] [ Time Frame: 12 weeks ]
    Percent
11. CGM-measured % below 70 mg/dL [extension study] [ Time Frame: 12 weeks ]
    Percent
12. CGM-measured % below 54 mg/dL [extension study] [ Time Frame: 12 weeks ]
    Percent
13. CGM-measured % above 250 mg/dL [extension study] [ Time Frame: 12 weeks ]
    Percent
14. Glucose variability measured with the coefficient of variation (CV) [extension study] [ Time Frame: 12 weeks ]
    Coefficient of variation- CGM measured

Other Outcome Measures:

1. % in range 70-140 mg/dL [main study] [ Time Frame: 16 weeks ]
   Percent - CGM measured
2. glucose variability measured with the standard deviation (SD) [main study] [ Time Frame: 16 weeks ]
   Standard Deviation- CGM measured
3. % <60 mg/dL [main study] [ Time Frame: 16 weeks ]
   Percent- CGM measured
4. Low blood glucose index [main study] [ Time Frame: 16 weeks ]
   index- CGM measured
5. Hypoglycemia events (defined as at least 15 consecutive minutes <70 mg\dL) [main study] [ Time Frame: 16 weeks ]
   mg/dL- CGM measured
6. % >300 mg/dL [main study] [ Time Frame: 16 weeks ]
   Percent- CGM measured
7. High blood glucose index [main study] [ Time Frame: 16 weeks ]
   index- CGM measured
8. % in range 70-180 mg/dL improvement from baseline to 16 weeks ≥5% [main study] [ Time Frame: 16 weeks ]
   Percent- CGM measured
9. % in range 70-180 mg/dL improvement from baseline to 16 weeks ≥10% [main study] [ Time Frame: 16 weeks ]
   Percent- CGM measured
10. HbA1c < 7.0% at 16 weeks [main study] [ Time Frame: 16 weeks ]
    Percent - HbA1c
11. HbA1c <7.5% at 16 weeks [main study] [ Time Frame: 16 weeks ]
    Percent - HbA1c
12. HbA1c improvement from baseline to 16 weeks >0.5% [main study] [ Time Frame: 16 weeks ]
    Percent - HbA1c
13. HbA1c improvement from baseline to 16 weeks >1.0% [main study] [ Time Frame: 16 weeks ]
    Percent - HbA1c
14. HbA1c relative improvement from baseline to 16 weeks >10% [main study] [ Time Frame: 16 weeks ]
    Percent - HbA1c
15. HbA1c improvement from baseline to 16 weeks >1.0% or HbA1c <7.0% [main study] [ Time Frame: 16 weeks ]
    Percent - HbA1c
16. Questionnaire - Fear of Hypoglycemia Survey (HFS-II) - total score, 2 subscales and 4 factor scores: 1- Behavior (avoidance and maintain high BG), 2- Worry (helplessness and social consequences) [main study] [ Time Frame: 16 weeks ]
    Questionnaire
17. Questionnaire - Clarke Hypoglycemia Awareness Scores [main study] [ Time Frame: 16 weeks ]
    Questionnaire
18. Questionnaire - Problem Areas in Diabetes Survey (PAID) [main study] [ Time Frame: 16 weeks ]
    Questionnaire
19. Questionnaire - INSPIRE survey scores [main study] [ Time Frame: 16 weeks ]
    Questionnaire
20. Questionnaire - PedsQL Diabetes Module - total score and 5 subscales: 1- Diabetes, 2 - Treatment I, 3 - Treatment II, 4 - Worry, 5 - Communication [main study] [ Time Frame: 16 weeks ]
    Questionnaire
21. Questionnaire - Pittsburgh Sleep Quality Index (Parent only) [main study] [ Time Frame: 16 weeks ]
    Questionnaire
22. Questionnaire - System Usability Scale (SUS) [main study] [ Time Frame: 16 weeks ]
    Questionnaire
23. Insulin - Total daily insulin (units/kg) [main study] [ Time Frame: 16 weeks ]
    units/kg
24. Insulin - Basal: bolus insulin ratio [main study] [ Time Frame: 16 weeks ]
    bolus insulin ratio
25. Weight and Body Mass Index (BMI) [main study] [ Time Frame: 16 weeks ]
    Weight and BMI
26. Time in range in extension study [ Time Frame: 12 weeks ]
    The primary outcome for the extension phase is improving % time in range 70-180 mg/dL by CGM when Control Group transitions to t:slim X2 with Control-IQ compared with the same group during the Main Phase.
27. % in range 70-140 mg/dL [extension study] [ Time Frame: 12 weeks ]
    Percent - CGM measured
28. glucose variability measured with the standard deviation (SD) [extension study] [ Time Frame: 12 weeks ]
    Standard Deviation- CGM measured
29. % <60 mg/dL [extension study] [ Time Frame: 12 weeks ]
    Percent- CGM measured
30. Low blood glucose index [extension study] [ Time Frame: 12 weeks ]
    index- CGM measured
31. Hypoglycemia events (defined as at least 15 consecutive minutes <70 mg\dL) [extension study] [ Time Frame: 12 weeks ]
    mg/dL- CGM measured
32. % >300 mg/dL [extension study] [ Time Frame: 12 weeks ]
    Percent- CGM measured
33. High blood glucose index [extension study] [ Time Frame: 12 weeks ]
    index- CGM measured
34. % in range 70-180 mg/dL improvement from 16 weeks to 28 weeks ≥5% [extension study] [ Time Frame: 12 weeks ]
    Percent- CGM measured
35. % in range 70-180 mg/dL improvement from 16 weeks to 28 weeks ≥10% [extension study] [ Time Frame: 12 weeks ]
    Percent- CGM measured
36. HbA1c < 7.0% at 28 weeks [extension study] [ Time Frame: 12 weeks ]
    Percent - HbA1c
37. HbA1c <7.5% at 28 weeks [extension study] [ Time Frame: 12 weeks ]
    Percent - HbA1c
38. HbA1c improvement from 16 weeks to 28 weeks >0.5% [extension study] [ Time Frame: 12 weeks ]
    Percent - HbA1c
39. HbA1c improvement from 16 weeks to 28 weeks >1.0% [extension study] [ Time Frame: 12 weeks ]
    Percent - HbA1c
40. HbA1c relative improvement from 16 weeks to 28 weeks >10% [extension study] [ Time Frame: 12 weeks ]
    Percent - HbA1c
41. HbA1c improvement from 16 weeks to 28 weeks >1.0% or HbA1c <7.0% [extension study] [ Time Frame: 12 weeks ]
    Percent - HbA1c
42. Questionnaire - Fear of Hypoglycemia Survey (HFS-II) - total score, 2 subscales and 4 factor scores: 1- Behavior (avoidance and maintain high BG), 2- Worry (helplessness and social consequences) [extension study] [ Time Frame: 12 weeks ]
    Questionnaire
43. Questionnaire - Clarke Hypoglycemia Awareness Scores [extension study] [ Time Frame: 12 weeks ]
    Questionnaire
44. Questionnaire - Problem Areas in Diabetes Survey (PAID) [extension study] [ Time Frame: 12 weeks ]
    Questionnaire
45. Questionnaire - INSPIRE survey scores [extension study] [ Time Frame: 12 weeks ]
    Questionnaire
46. Questionnaire - PedsQL Diabetes Module - total score and 5 subscales: 1- Diabetes, 2 - Treatment I, 3 - Treatment II, 4 - Worry, 5 - Communication [extension study] [ Time Frame: 12 weeks ]
    Questionnaire
47. Questionnaire - Pittsburgh Sleep Quality Index (Parent only) [extension study] [ Time Frame: 12 weeks ]
    Questionnaire
48. Questionnaire - System Usability Scale (SUS) [extension study] [ Time Frame: 12 weeks ]
    Questionnaire
49. Insulin - Total daily insulin (units/kg) [extension study] [ Time Frame: 12 weeks ]
    units/kg
50. Insulin - Basal: bolus insulin ratio [extension study] [ Time Frame: 12 weeks ]
    bolus insulin ratio
51. Weight and Body Mass Index (BMI) [extension study] [ Time Frame: 12 weeks ]
    Weight and BMI

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. Weight ≥25 kg and ≤140 kg
5. 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.
6. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
7. 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
8. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol

9. 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
10. Total daily insulin dose (TDD) at least 10 U/day
11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
12. 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

Locations

United States, California

Stanford University

Stanford, California, United States, 94304

United States, Colorado

Barbara Davis Center, University of Colorado

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06511

United States, Virginia

UVA Center for Diabetes Technology

Charlottesville, Virginia, United States, 22903

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

  Study Documents (Full-Text)

Documents provided by University of Virginia:

Informed Consent Form  [PDF] January 25, 2019

Study Protocol  [PDF] October 9, 2019

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT03844789
• Other Study ID Numbers: DCLP5
• First Posted: February 18, 2019
• Last Update Posted: December 7, 2020
• Last Verified: November 2020

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

Keywords provided by University of Virginia:

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

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases