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

Last updated May 16, 2026

Key finding

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.

This case report describes the youngest known use of a hybrid closed-loop insulin system in a 29-day-old infant with neonatal diabetes. The automated system improved blood sugar control and eliminated dangerous low blood sugar episodes when used with diluted U10 insulin, allowing the baby to feed normally without carbohydrate counting.

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Study at a glance

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EvidenceScore™

Low

Study type

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

Follow-up

Short-Term (≤3 mo)

Risk of bias

High Risk

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Plain-language summary

What this paper says

A plain-language read of the study’s main message and where it applies.

Study focus

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.

Published in

Journal Reference

Publication details and source links for this paper.

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

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 suggest

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

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

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

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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