A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
Stanford University
Stanford, California, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Primary Outcome
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 70 mg/dl.
Percent of time spent below 70 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 60 mg/dl.
Percent of time spent below 60mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 54 mg/dl.
Percent of time spent below 54mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 50mg/dl.
Percent of time spent below 50mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 180 mg/dl.
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Percent of time spent above 180mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 250mg/dl.
Percent of time spent above 250mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 300 mg/dl.
Percent of time spent above 300 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Between 70-140mg/dl.
Percent of time spent between 70 mg/dl and 140mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Between 70-180mg/dl
Percent of time spent between 70 mg/dl and 180mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Number of Hypoglycemia Below 70 mg/dL
Number of hypoglycemia events (below 70 mg/dL).
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Average Number of Treatments.
Average number of carbohydrate treatments per day. Participants were treated with \~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \~20min. Hypoglycemic treatments could occur at any time per study physician request
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Average of Carbohydrate Treatments (g).
Average amount of carbohydrates (grams) used as a treatment. Participants were treated with \~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \~20min. Hypoglycemic treatments could occur at any time per study physician request
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Percent of Time Spent in Closed Loop
Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
CGM Consensus Goal
Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.