Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

Not Applicable

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT04084171
• Lead Sponsor: University of Virginia

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Study Start: 2019-09-26
• Primary Completion: 2019-10-23
• Study Completion: 2019-10-23
• Results First Submitted: 2022-10-28
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Results First Posted: 2023-03-22
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age ≥ 2 and < 6 years old at the time of consent
2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment
3. Use of an insulin pump in the past 3 months
4. Use of Dexcom G6 for at least 11 out of the last 14 days
5. Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses
6. Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
7. At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team
8. Investigator has confidence that the parent/guardian(s) 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 already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
10. Total daily insulin dose (TDD) of at least 5 U/day
11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
12. Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff
13. Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study
14. Willingness to wear a Dexcom G6 sensor during the entire study
15. An understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria

1. Hypoglycemia induced seizure or loss of consciousness in the past 3 months

2. Diabetes Ketoacidosis in the past 3 months

3. Use of diluted insulin

4. Concurrent use of any non-insulin glucose-lowering agent

5. Hemophilia or any other bleeding disorder

6. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include:

   • Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea)
   • Addison's disease
   • Diagnosed at less than 1 year of age without positive antibodies
   • Decreased renal function
   • Cystic fibrosis
   • Other chronic conditions, such as an underlying seizure disorder

7. Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

8. Having a family member(s) 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Outcome	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.	Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.

Secondary Outcome Measures

Name	Time	Method
Below 70 mg/dl.	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.	Percent of time spent below 70 mg/dl.
Below 60 mg/dl.	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.	Percent of time spent below 60mg/dl.
Below 54 mg/dl.	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.	Percent of time spent below 54mg/dL.
Above 250mg/dl.	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.	Percent of time spent above 250mg/dl.
Above 300 mg/dl.	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.	Percent of time spent above 300 mg/dl.
Between 70-140mg/dl.	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.	Percent of time spent between 70 mg/dl and 140mg/dl.
Average of Carbohydrate Treatments (g).	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 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
Number of Hypoglycemia Below 70 mg/dL	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 events (below 70 mg/dL).
Above 180 mg/dl.	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.	Percent of time spent above 180mg/dl.
Percent of Time Spent in Closed Loop	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.	Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.
Below 50mg/dl.	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.	Percent of time spent below 50mg/dL.
Average Number of Treatments.	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 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
CGM Consensus Goal	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.	Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.
Between 70-180mg/dl	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.	Percent of time spent between 70 mg/dl and 180mg/dl.

Trial Locations

Locations (3)

Barbara Davis Center, University of Colorado; 🇺🇸 Aurora, Colorado, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Virginia Center for Diabetes Technology; 🇺🇸 Charlottesville, Virginia, United States