Devices & Monitoring
RESEARCH SUMMARY

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 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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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

Sources

Ranked by clinical relevance and evidence quality.

Key References

Most relevant evidence and guidance related to this research.

1
Guideline

International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024: Diabetes Technologies - Insulin Delivery

ISPAD clinical practice consensus guidelines on insulin delivery technologies including insulin pumps and hybrid closed-loop systems, providing the framework for use across pediatric age groups.
2
Guideline

CGM & Time in Range | American Diabetes Association

Understand the benefits of time in range (TIR) with continuous glucose monitors. Compare TIR vs A1C to better manage your blood glucose levels for a healthier lifestyle.
3
Guideline

International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024: Diabetes Technologies - Glucose Monitoring

ISPAD clinical practice consensus guidelines outlining standards for CGM use in pediatric diabetes, including children of all ages, supporting the use of diabetes technology in young children.

14 total sources in this category

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