Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes
Authors' conclusion
URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants.
Study context
- Population
- Children, adolescents and adults with T1D (age 6–75 years), 14 U.S. diabetes centers
- Participants
- 179 children
- Comparison
- URLi vs lispro in Control-IQ 1.5 pump
- Outcome
- Safety of URLi in t:slim X2 pump with Control-IQ 1.5
- Follow-up
- 13 weeks
Methodological details16-day lead-in with lispro, 13-week URLi period
- 16-day lead-in with lispro
- 13-week URLi period
Main finding
As reported in the abstract
Safety
Severe hypoglycemia with URLi, attributed to override boluses or a missed meal
1.7%
3 participants
DKA events
0
Stopped URLi due to infusion-site discomfort
2 participants
Stopped URLi after developing a rash
1 participant
Further findings
| Outcome | Mean difference (95% CI) | P value | |
|---|---|---|---|
| Insulin treatment satisfaction questionnaire score · screening to 13 weeks of URLiURLi (13 weeks)vs Screening | 6 (4–8) | P < 0.001 | |
| −50510Difference (linear scale) |
| Outcome | URLi | Lispro | P value |
|---|---|---|---|
| TIR 70-180 mg/dLIncreased with URLi | mean 67% ± 13% | mean 65% ± 15% | P = 0.004 |
- Insulin treatment satisfaction questionnaire score: improved from 75 ± 13 to 80 ± 11; greatest improvement for confidence avoiding symptoms of high blood sugar
TRIM-Diabetes score
- Mean score improved from 74 ± 12 to 80 ± 12
- P < 0.001
TRIM-Diabetes Device score
- Mean score improved from 82 ± 11 to 86 ± 12
- P < 0.001
Safety
Adverse events with URLi · 13 weeks
- Severe hypoglycemia
- 1.7% (3 participants)
- DKA events
- 0
- Stopped URLi: infusion-site discomfort
- 2
- Stopped URLi: rash
- 1
Original publication
Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. Published 22 May 2024. doi:10. 1089/ dia. 2024. 0048
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