Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study
Authors' conclusion
SH and DKA rates were lower for users of t:slim X2 with Control-IQ technology compared to historical data for both adults and children. Real-world use of this AHCL system proved safe and effective in this virtual study design.
Study context
- Population
- Individuals with T1D aged ≥6 years starting t:slim X2 with Control-IQ, real-world outpatient setting; enrolled August 2020–March 20222,998 completed 12 months
- Participants
- 3,157 individuals
- Exposure
- Control-IQ users vs historical T1D Exchange data
- Outcome
- Adverse event (AE) rates (SH and diabetic ketoacidosis (DKA)), reported monthly, compared with historical T1D Exchange data
- Follow-up
- 12 months
Methodological detailssingle-arm, longitudinal, virtual study visits, comparison with historical data (T1D Exchange), All study visits were virtual
- Single-arm
- Longitudinal
- Virtual study visits
- Comparison with historical data (T1D Exchange)
- All study visits were virtual
Main finding
As reported in the abstract
SH rate vs historical T1D Exchange data
Severe hypoglycemia (SH) rate, children: CLIO vs historic rates
9.31 vs. 19.31 events/100 patient years, d = 0.29
P < 0.01
SH rate, adults: CLIO vs historic rates
9.77 vs. 29.49 events/100 patient years, d = 0.53
P < 0.01
Observational data: associations, not effects.
Further findings
TIR 70-180 mg/dL
- Adults
- 70.1% (61.0-78.8)
- Age 6-13
- 61.2% (52.4-70.5)
- Age 14-17
- 60.9% (50.1-71.8)
- Overall
- 67.3% (57.4-76.9)
Patient-reported outcomes
- Reduction in diabetes burden consistently reported
Original publication
Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study. Diabetes Technol Ther. Published 26 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →