Control-IQ Observational (CLIO) Post-Approval Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Control-IQ Observational (CLIO) Post-Approval Study

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: t:slim X2 pump with Control-IQ technology


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pump Naive<br>New to insulin pump use | Device: t:slim X2 pump with Control-IQ technology<br>* Real-world use<br>|
| 6-13 YO<br>Subjects between the age of 6-13 years old. | Device: t:slim X2 pump with Control-IQ technology<br>* Real-world use<br>|
| 14-17 YO<br>Subjects between the age of 14-17 years old. | Device: t:slim X2 pump with Control-IQ technology<br>* Real-world use<br>|
| Adults (18+)<br>Subjects are 18 years old and older. | Device: t:slim X2 pump with Control-IQ technology<br>* Real-world use<br>|
| CGM Naive<br>Subjects have not used CGM in the 30 days prior to enrollment. | Device: t:slim X2 pump with Control-IQ technology<br>* Real-world use<br>|
| HbA1c more than or equal to 8.5%<br>Subjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment. | Device: t:slim X2 pump with Control-IQ technology<br>* Real-world use<br>|
| HbA1c less than or equal to 8.5%<br>Subjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment. | Device: t:slim X2 pump with Control-IQ technology<br>* Real-world use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rates of Severe Hypoglycemia (SH) | Overall incidence rate of events per 100 patient years | 12 months | 
| Incidence Rates of Diabetic Ketoacidosis (DKA) | Overall incidence rate of events per 100 patient years | 12 months | 
| Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | 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. | 12 months | 

Secondary Outcome Measures

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