Control-IQ Observational (CLIO) Post-Approval Study

Completed

Brief Summary: Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).

Detailed Description: Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.

Recruitment & Eligibility

Inclusion Criteria

Patients with self-reported type 1 diabetes who have been prescribed the Control-IQ system.
At least 6 years of age
Using Humalog or Novolog insulin
For females, not pregnant or planning pregnancy in the next 12 months.
Agreement to use the t:slim X2 with Control-IQ technology, 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 to respond to alerts and alarms, and to provide basic diabetes self-management.
Patients who 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. Patients unable to use t:connect Mobile application must be willing to manually upload their insulin pump data to t:connect every three months and at the completion of the study.
Subject has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).

Exclusion Criteria

Self-reported type 2 diabetes
< 6 years of age
Use of any glucose-lowering therapy other than Humalog or Novolog insulin
Inability to respond to alerts and alarms, or to provide basic diabetes self-management.
Pregnancy
Subjects who have not signed the ICF.

Primary Outcome Measures

Name	Time	Method
Incidence Rates of Severe Hypoglycemia (SH)	12 months	Overall incidence rate of events per 100 patient years
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature	12 months	Percent of boluses using the auto population feature resulting in at least one reading less than 70 mg/dL than those not using the feature, in every pre-bolus glucose range examined.
Incidence Rates of Diabetic Ketoacidosis (DKA)	12 months	Overall incidence rate of events per 100 patient years

Secondary Outcome Measures

Name	Time	Method
Percent Time Greater Than 250 mg/dL	12 months	CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use
Percent Time Greater Than 180 mg/dL	12 months	CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use
Percent Time Less Than 54 mg/dL	12 months	CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use
Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score	12 months	DIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome.
Diabetes Impact and Satisfaction Scale (DIDS), Impact Score	12 months	DIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome.
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 Less Than 70 mg/dL	12 months	CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use