Clinical trial NCT06717451: PS230005 Control-IQ 1.5 Post-Approval Study
Official title: PS230005 Control-IQ 1.5 Post-Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
Control-IQ
Control-IQ 1.5
Tandem
mobi
t:slim X2
automated insulin delivery
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
First posted: 2024-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollment in the study will be available to all individuals age 2 to \<6 years of age at time of screening who start therapy with Control-IQ Technology v1.5.

Brief summary: This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to \<6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.

Detailed description: The study will recruit participants age 2 to \<6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.

Eligibility criteria: Inclusion Criteria:

* Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump
* Age 2 to \<6 years at time of screening
* Using an insulin approved for use in the pump
* Using an iCGM sensor approved for use with the pump
* Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.
* Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
* Ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
* Reside full-time in the United States.
* Willingness to download the t:connect Mobile application to their smartphone and keep it active throughout the study if using a Tandem t:slim X2 pump. Participants who are unable to use the t:connect mobile application must be willing to manually upload their insulin pump data to Tandem Source every three months and at the completion of the study.
* Participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).

Exclusion Criteria:

* Use of any glucose-lowering therapy other than insulin.
* A medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study.

Primary outcomes:
measure: Incidence Rates of Severe Hypoglycemia (SH)
timeFrame: 12 months
measure: Incidence Rates of Diabetic Ketoacidosis (DKA)
timeFrame: 12 months
Secondary outcomes:
measure: Percent Time in Range 70 - 180 mg/dL
timeFrame: 12 months
measure: Percent Time Greater Than 180 mg/dL
timeFrame: 12 months
measure: Percent Time Greater Than 250 mg/dL
timeFrame: 12 months
measure: Percent Time Less Than 70 mg/dL
timeFrame: 12 months
measure: Percent Time Less Than 54 mg/dL
timeFrame: 12 months
measure: Mean Glucose mg/dL
timeFrame: 12 months
Other outcomes:
measure: Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score
timeFrame: 12 months
measure: Diabetes Impact and Satisfaction Scale (DIDS), Impact Score
timeFrame: 12 months
measure: EQ-5D (inclusive of the Visual Analogue Scale (VAS))
timeFrame: 12 months
measure: Hypoglycemia Fear Survey - Parent for Young Children Version (HFS-P-YC)
timeFrame: 12 months
Locations:
city: San Diego
country: United States
facility: Tandem Diabetes Care
state: California
Study officials:
affiliation: Chief Medical Officer, Tandem Diabetes Care
name: Jordan Pinsker, MD
role: PRINCIPAL_INVESTIGATOR
References: