Control-IQ Observational (CLIO) Post-Approval Study
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pump Naiive New to insulin pump use |
Device: t:slim X2 pump with Control-IQ technology
Real-world use
|
| 6-13 YO Subjects between the age of 6-13 years old. |
Device: t:slim X2 pump with Control-IQ technology
Real-world use
|
| 14-17 YO Subjects between the age of 14-17 years old. |
Device: t:slim X2 pump with Control-IQ technology
Real-world use
|
| Adults (18+) Subjects are 18 years old and older. |
Device: t:slim X2 pump with Control-IQ technology
Real-world use
|
| CGM Naiive Subjects have not used CGM in the 30 days prior to enrollment. |
Device: t:slim X2 pump with Control-IQ technology
Real-world use
|
| HbA1c more than or equal to 8.5% 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
Real-world use
|
| HbA1c less than or equal to 8.5% 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
Real-world use
|
Outcome Measures
Primary Outcome Measures
- Incidence rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) [12 months]
Overall incidence rate of X events per 100 patient years
- Safety of the automatic population of CGM readings into the bolus calculator of the Control-IQ system [12 months]
Correlating the incidence of AE with the use of the calculator and associated CGM readings.
Secondary Outcome Measures
- Glycemic Outcomes as a measure of efficacy of the Control-IQ system [12 months]
means/medians as appropriate based on the data extracted
- Patient-reported satisfaction with and trust in the Control-IQ system, usability of the system, and sleep quality [12 months]
means/medians as appropriate based on the data extracted
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tandem Diabetes | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Tandem Diabetes Care, Inc.
- University of California, San Diego
Investigators
- Principal Investigator: Jordan Pinsker, MD, Tandem Diabetes Care, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLIO Study