N/A
Completed N=3,061
Control-IQ Observational (CLIO) Post-Approval Study
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT04503174 ↗
Enrolled (actual)
3,061
Serious AEs
0.5%
Results posted
Dec 2023
Primary outcomePrimary: Incidence Rates of Severe Hypoglycemia (SH) — 9.65; 9.31; 9.77; 7.99 events per 100 patient years
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rates of Severe Hypoglycemia (SH) |
9.65; 9.31; 9.77; 7.99; 9.58; 9.66 | — |
| PRIMARY Incidence Rates of Diabetic Ketoacidosis (DKA) |
2.40; 1.93; 1.46; 3.57; 2.47; 0.96 | — |
| PRIMARY Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature |
13.18; 14.52; 11.06; 15.61; 10.34; 13.50 | — |
| SECONDARY Percent Time in Range 70 - 180 mg/dL |
70.1; 60.9; 61.2; 67.3 | — |
| SECONDARY Percent Time Greater Than 180 mg/dL |
28.6; 37.0; 37.2; 31.4 | — |
| SECONDARY Percent Time Greater Than 250 mg/dL |
6.3; 12.8; 12.7; 8.0 | — |
| SECONDARY Percent Time Less Than 70 mg/dL |
1.1; 1.0; 1.1; 1.1 | — |
| SECONDARY Percent Time Less Than 54 mg/dL |
0.2; 0.2; 0.2; 0.2 | — |
| SECONDARY Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score |
9.14 | — |
| SECONDARY Diabetes Impact and Satisfaction Scale (DIDS), Impact Score |
2.75 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04503174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.