Clinical trial NCT03844789: A Study of t:Slim X2 With Control-IQ Technology
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Tandem Diabetes Care, Inc.
name: DexCom, Inc.
name: Jaeb Center for Health Research
First posted: 2019-02-18
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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 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
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

Primary outcomes:
measure: Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period
timeFrame: From randomization to data collection completion at the end of 16 weeks
Secondary outcomes:
measure: CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-Measured Mean Glucose Over 16 Week Trial Period
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period
timeFrame: At data collection completion at the end of 16 weeks
measure: CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: CGM-measured Mean Glucose Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
Other outcomes:
measure: CGM-Measured Percent of Time in Range 70-140 mg/dL Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Glucose Variability Measured With the Standard Deviation (SD) Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-Measured Percent of Time Below 60 mg/dL Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Low Blood Glucose Index (LBGI) Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes <70 mg\dL) Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-Measured Percent of Time >300 mg/dL Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: High Blood Glucose Index (HBGI) Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥5%
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥10%
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Absolute Glycated Hemoglobin Percent HbA1c Improvement From Baseline to 16 Weeks Greater Than 0.5%
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Absolute Glycated Hemoglobin Percent (HbA1c) Improvement From Baseline to 16 Weeks Greater Than 1.0%
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Glycated Hemoglobin Percent (HbA1c) Relative Improvement From Baseline to 16 Weeks Greater Than 10%
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Glycated Hemoglobin Percent HbA1c Reduction From Baseline to 16 Weeks Greater Than 1.0% or HbA1c Less Than 7.0%
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks
timeFrame: At data collection completion at the end of 16 weeks
measure: Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks
timeFrame: At data collection completion at the end of 16 weeks
measure: Problem Areas in Diabetes Survey (PAID) at 16 Weeks
timeFrame: At data collection completion at the end of 16 weeks
measure: Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expections (INSPIRE) Survey Scores at 16 Weeks
timeFrame: At data collection completion at the end of 16 weeks
measure: Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks
timeFrame: At data collection completion at the end of 16 weeks
measure: Pittsburgh Sleep Quality Index (Parent Only) at 16 Weeks (Parent Only)
timeFrame: At data collection completion at the end of 16 weeks
measure: System Usability Scale (SUS) at 16 Weeks
timeFrame: At data collection completion at the end of 16 weeks
measure: Total Daily Insulin (Units/kg/Day) Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Basal: Bolus Insulin Ratio Over 16 Weeks
timeFrame: 7 days leading up to the final study visit in week 16
measure: Weight at 16 Weeks
timeFrame: At data collection completion at the end of 16 weeks
measure: CGM-Measured Percent of Time in Range 70-180mg/dL Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: CGM-Measured Percent of Time in Range 70-140 mg/dL Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: Glucose Variability of Blood Sugar as Measured by Continuous Glucose Monitor (CGM), Measured With the Standard Deviation (SD) Over 16 Weeks
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: Continuous Blood Glucose Monitor (CGM)-Measured Percent of Time Less Than 60 mg/dL Over 16 Weeks
timeFrame: From randomization to data collection completion at the end of 16 weeks
measure: Continuous Blood Glucose Monitor (CGM)-Measured Low Blood Glucose Index (LBGI) Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: Number of Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes Less Than 70 mg\dL as Measured by Continuous Glucose Meter) Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: CGM-Measured Percent of Time Above 300 mg/dL Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: High Blood Glucose Index (HBGI) Over 12 Weeks of Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Pittsburgh Sleep Quality Index (Parent Only) at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
measure: Total Daily Insulin (TDI) (Units/kg/Day) Over 12 Week Trial Extension Period
timeFrame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
measure: Basal: Bolus Insulin Ratio at Conclusion of 12 Week Trial Extension Period
timeFrame: 7 days leading up to the final extension study visit in week 28
measure: Body Mass Index (BMI) at Conclusion of 12 Week Trial Extension Period
timeFrame: At completion of the extension study, end of week 28
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center, University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Charlottesville
country: United States
facility: UVA Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia
name: Melissa J Schoelwer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.