A 13-Week Single-Arm Evaluation of Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes
Main finding · Daytime TIR 70-180 mg/dLResult — go to the resultMean change 5.1% 95% CI 0.3%–9.8%Authors' conclusion
In adults with T1D, glycemic outcomes were comparable or slightly better with TI-degludec after switching from AID or MDI.
Study context
- Population
- Adults with T1D who completed 17 weeks in the usual-care control group of a randomized trial
- Participants
- 49 adults
- Comparison
- Technosphere insulin (TI) plus insulin degludec for 13 weeks vs baseline
- Baselinen = 49reference
- TI-degludecn = 49
- Outcome
- Noninferiority for daytime TIR 70-180 mg/dL
- Follow-up
- 13 weeks
Methodological detailsnoninferiority, extension of usual-care control group of a randomized trial
- Noninferiority
- Extension of usual-care control group of a randomized trial
Main finding
Daytime TIR 70-180 mg/dL
Mean change
5.1%
95% CI 0.3%–9.8%
noninferiority P < 0.001
By group
TI-degludecvs Baseline
mean change 5.1% (95% CI 0.3%–9.8%); noninferiority P < 0.001
As reported in the abstract
- Increase vs baseline multiple daily injections (MDI)/sensor-augmented pump (SAP)
- 8.6%
Further findings
| Outcome | Mean change (%) (95% CI) | P value | |
|---|---|---|---|
| HbA1c change from baseline · 13 weeks | −0.23 (−0.42% to −0.04%) | noninferiority P < 0.001, superiority P = 0.02 | |
| −0.6−0.4−0.200.2Difference, % (linear scale) |
| Outcome | P value |
|---|---|
| Participants meeting HbA1c target <7.0% · 13 weeks | P = 0.02 |
- HbA1c change from baseline — Mean change vs baseline MDI/SAP
- −0.36%
- HbA1c change from baseline — Mean change vs baseline automated insulin delivery (AID)
- 0.0%
Participants meeting HbA1c target <7.0% · 13 weeks
- Participants meeting HbA1c target <7.0% increased from 14% to 31%
Overnight time-in-range (TIR) by baseline delivery method
- Baseline AID users: overnight TIR decreased when switched to TI-degludec
- 15.6%
- Baseline MDI/SAP users: overnight TIR increased
- 2.0%
Desire to continue using TI · 13 weeks
- Participants indicating desire to continue TI
- 40%
Safety
| Outcome | Baseline | TI-degludec | Mean change (95% CI) | |
|---|---|---|---|---|
| Time <54 mg/dL · 13 weeks | mean 0.5% ± 0.7% | mean 0.7% ± 0.8% | 0.2% (−0.1% to 0.5%) | |
| −0.200.20.40.6Difference (linear scale) |
Original publication
A 13-Week Single-Arm Evaluation of Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes. Diabetes Technol Ther. Published 1 March 2025. doi:10.
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