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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 101
- Locations
- 4
- Primary Endpoint
- Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 X
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM (Device)
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.
Intervention: Control Group (Device)
Outcomes
Primary Outcomes
Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period
Time Frame: From randomization to data collection completion at the end of 16 weeks
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.
Secondary Outcomes
- 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)
- 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 Percent of Time Above 250 mg/dL Over 16 Week Trial Period(From randomization to data collection completion at the end of 16 weeks)
- Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period(From randomization to data collection completion at the end of 16 weeks)
- CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period(From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks)
- CGM-measured Mean Glucose Over 12 Week Trial Extension Period(From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks)
- Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period(At completion of the extension study, end of week 28)
- CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period(From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks)
- CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period(From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks)
- CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period(From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks)
- Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period(From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks)