First in Human Feasibility Study: Automated Insulin Delivery Utilizing a Self-Adapting Algorithm in Adults With Type 1 and Type 2 Diabetes
Authors' conclusion
A closed-loop algorithm that adjusts its own parameters and requires no meal announcement was feasible in a cohort of adults with type 1 and type 2 diabetes. Clinical benefits were most apparent with the fully adapted algorithm.
Study context
- Population
- Adults with T1D and T2D using a novel self-adapting closed-loop system that does not require carbohydrate announcementenrolled
- Participants
- 32 vs 10
- Comparison
- Self-adapting closed-loop system without carbohydrate announcement (12 weeks) vs usual insulin therapy run-in (baseline)
- T1Dn = 32
- T2Dn = 10
- Outcome
- TIR (% CGM readings 70-180 mg/dL), baseline vs intervention period
- Follow-up
- 12 weeks
Methodological detailsfirst in human, 14-day run-in with blinded continuous glucose monitor (CGM), Algorithm adjusted its own parameters after 4, 6, 8, and 10 weeks of use
- First in human
- 14-day run-in with blinded CGM
- Algorithm adjusted its own parameters after 4, 6, 8, and 10 weeks of use
Main finding
As reported in the abstract
TIR (% CGM readings 70-180 mg/dL), baseline vs intervention period · 12 weeks T1D mean 55.9% · T2D mean 51.5%
Baseline
Further findings
Median daily insulin delivered by manual bolus · consistent with no meal announcement
Time in range (TIR) following the fourth algorithm adaptation
- Median TIR following the fourth algorithm adaptation
- 65%
Safety
Median
| Outcome | T1D | T2D |
|---|---|---|
| Time <70 mg/dL during intervention period | 1.1% | 0.0% |
Serious adverse events
- Serious adverse events
- 4
- Worsening retinopathy
- 1
- Severe hypoglycemia following a period of paused automation
- 1
- Hospitalizations unrelated to the device
- 2
Original publication
First in Human Feasibility Study: Automated Insulin Delivery Utilizing a Self-Adapting Algorithm in Adults With Type 1 and Type 2 Diabetes. J Diabetes Sci Technol. Published 3 July 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →