Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, Control-IQ, Control-IQ 1.5, Tandem, mobi, t:slim X2, automated insulin delivery
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.
Interventions
DEVICEControl-IQ Technology v1.5
Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ technology v1.5. Every month participants will receive a survey to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment. Participants will also complete surveys related to patient reported outcomes at baseline, 6 months, and 12 months.
Sponsors
Tandem Diabetes Care, Inc.
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rates of Severe Hypoglycemia (SH) | 12 months | Overall incidence rate of SH events per 100 patient years during 12 months of Control-IQ use |
| Incidence Rates of Diabetic Ketoacidosis (DKA) | 12 months | Overall incidence rate of DKA events per 100 patient years during 12 months of Control-IQ use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time in Range 70 - 180 mg/dL | 12 months | CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use |
| Percent Time Greater Than 180 mg/dL | 12 months | CGM measured percent time \>180 mg/dL during 12 months of Control-IQ use |
| Percent Time Greater Than 250 mg/dL | 12 months | CGM measured percent time \>250 mg/dL during 12 months of Control-IQ use |
| Percent Time Less Than 70 mg/dL | 12 months | CGM measured percent time \<70 mg/dL during 12 months of Control-IQ use |
| Percent Time Less Than 54 mg/dL | 12 months | CGM measured percent time \<54 mg/dL during 12 months of Control-IQ use |
| Mean Glucose mg/dL | 12 months | CGM measured mean glucose during 12 months of Control-IQ use |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJordan Pinsker, MD
Chief Medical Officer, Tandem Diabetes Care
Outcome results
None listed