Hybrid closed-loop insulin system safely controls blood sugar in a 29-day-old infant with neonatal diabetes

Low confidence

high bias

Last updated May 16, 2026

Key takeaway:

A hybrid closed-loop insulin delivery system successfully managed blood glucose in a 29-day-old infant with neonatal diabetes, using diluted U10 insulin to eliminate dangerous hypoglycemia while allowing normal feeding without carb counting.

Study at a glance

What was studied

Hybrid closed-loop system in a 29-day-old with neonatal diabetes

Study type

non-randomized clinical trial (non-RCT or NRCT)

duration

Short-Term (≤3 mo)

Intervention

Hybrid closed-loop system

Outcomes

Time in range, Time below range, Time above range, Glucose variability, Blood glucose, HbA1c

Funding

Non-industry sponsored

Main effects

Hybrid closed-loop system ↑ Time in range from 6.6% to 45.5-56.9% ↓

Diluted U10 insulin eliminated hypoglycemia (0% time below range) ↓

HbA1c reached 4.8% at 2 months post-discharge with minimal hypoglycemia ↓

Evidence Summary

Intervention	Outcome	Measured Change	Study Effect
Hybrid closed-loop system (Devices & Technology)	Blood glucose (Glycemic Control)	Decrease	Strong
Hybrid closed-loop system (Devices & Technology)	Glucose variability (Glycemic Control)	Decrease	Strong
Hybrid closed-loop system (Devices & Technology)	HbA1c (Glycemic Control)	Decrease	Limited
Hybrid closed-loop system (Devices & Technology)	Time above range (Glycemic Control)	Decrease	Strong
Hybrid closed-loop system (Devices & Technology)	Time below range (Glycemic Control)	Decrease	Strong
Hybrid closed-loop system (Devices & Technology)	Time in range (Glycemic Control)	Increase	Strong

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Evidence Suggest

HCLS with diluted U10 insulin achieved safe glycemic control in a 29-day-old NDM infant
Omission of carbohydrate dosing allowed normal ad-libitum feeding without glucose compromise
Automated insulin delivery eliminated severe hypoglycemia compared to IV/subcutaneous regimen

Who this applies to

This case applies to infants diagnosed with neonatal diabetes mellitus who require insulin treatment, particularly those with transient forms due to chromosome 6q24 abnormalities or other genetic causes requiring insulin therapy.

Keep in Mind

This is a single case report, not a controlled trial. The off-label use of HCLS requires regulatory considerations, specialized caregiver education, and compounded diluted insulin with limited shelf life (28 days). Results may not apply to all NDM subtypes or across all available HCLS platforms.

Between the Lines

Single case report with no control group (n=1)
Short observation period (7 days per treatment modality)
Not generalizable without further study in larger NDM populations

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Journal Reference

Ghaben AL, Byer-Mendoza C, McNamara K, et al. Implementation of a Hybrid Closed-Loop Automated Insulin Delivery System in a 29-Day Infant With Neonatal Diabetes. JCEM Case Rep. 2026;4(3):luaf338. doi:10.1210/jcemcr/luaf338