Evidence Intelligence™
- EvidenceScore™
- 68
- Moderate
- ImpactScore™
- 100
- Very Positive
- ConsistencyScore™
- 100
- consistent
Supporting studies: Based on 3 studies
Add to Evidence TrackerDevices & Monitoring
Research Summary
Analyzed using Evidence Intelligence™
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.
Quick read
Study at a glance
The essential study design details in one scan.
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 network
How this study fits
Understand where this research contributes within the broader evidence network.
Evidence Context
This study contributes evidence to Hybrid closed-loop system and Blood glucose, Glucose variability, HbA1c, and 3 more.
This study contributes evidence to
Primary intervention
Hybrid closed-loop system
Primary outcomes
- Blood glucose
- Glucose variability
- HbA1c
Primary intervention
Primary outcomes
Evidence relationships
Intervention and outcome relationships this study adds to the evidence network.
6
Evidence pairs
6
Relationships
4
Evidence topics
contributes_evidence
Editorial context
Why this study matters
See why this paper is useful beyond its individual results.
Evidence network role
This section describes how the study fits into the current evidence network. It does not determine whether an intervention works on its own.
Moderate contributionModerate confidenceNetwork score: 54
4
Related topics
6
Evidence pairs
578
Related studies
High relevance in at least one topic
Why it is useful
- Contributes to 6 evidence relationships
- Uses a randomized study design signal
- Linked to 4 direct semantic evidence topics
Topic contributions
Evidence topic
Contributes evidence
Evidence topic
Contributes evidence
Evidence topic
Contributes evidence
Evidence topic
Contributes evidence
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Primary evidence
Evidence relationship
Insulin Delivery Systems and CGM Time in Range
Related evidence
Evidence relationship
Insulin Delivery Systems and HbA1c
Save evidence
Evidence relationship
Insulin Delivery Systems and Glucose Variability
Save evidence
Core evidence
Study findings
The primary outcomes reported in this study.
Glucose variability
Hybrid closed-loop system → Glucose variability
Hybrid closed-loop system → Glucose variability
Evidence Intelligence™
- EvidenceScore™
- 69
- Moderate
- ImpactScore™
- 73
- Positive
- ConsistencyScore™
- 75
- consistent
Supporting studies: Based on 4 studies
Add to Evidence TrackerEvidence Intelligence™
- EvidenceScore™
- 80
- Strong
- ImpactScore™
- 92
- Very Positive
- ConsistencyScore™
- 100
- consistent
Supporting studies: Based on 5 studies
Add to Evidence TrackerTime above range
Hybrid closed-loop system → Time above range
Hybrid closed-loop system → Time above range
Evidence Intelligence™
- EvidenceScore™
- 68
- Moderate
- ImpactScore™
- 86
- Very Positive
- ConsistencyScore™
- 100
- consistent
Supporting studies: Based on 4 studies
Add to Evidence TrackerTime below range
Hybrid closed-loop system → Time below range
Hybrid closed-loop system → Time below range
Evidence Intelligence™
- EvidenceScore™
- 65
- Moderate
- ImpactScore™
- 81
- Positive
- ConsistencyScore™
- 67
- generally_consistent
Supporting studies: Based on 3 studies
Add to Evidence TrackerEvidence Intelligence™
- EvidenceScore™
- 81
- Strong
- ImpactScore™
- 87
- Very Positive
- ConsistencyScore™
- 83
- consistent
Supporting studies: Based on 8 studies
Add to Evidence TrackerEvidence Library
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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
Evidence Library
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Connected Evidence
Explore related studies, evidence collections, and research questions.
Relationships organized using the Dediabetes Evidence Intelligence™ framework.
This study contributes to evidence on Insulin Delivery Systems and CGM Time in Range, Insulin Delivery Systems and HbA1c.
Related evidence relationships
Explore in Evidence ExplorerThis study contributes to the evidence on the following intervention-outcome relationships.
Devices & Technology
Insulin Delivery Systems → CGM Time in Range
Devices & Technology
Evidence Intelligence™
- EvidenceScore™
- 81
- Strong
- ImpactScore™
- 87
- Very Positive
- ConsistencyScore™
- 83
- consistent
Supporting studies: Based on 8 studies
View evidenceDevices & Technology
Insulin Delivery Systems → HbA1c
Devices & Technology
Evidence Intelligence™
- EvidenceScore™
- 80
- Strong
- ImpactScore™
- 92
- Very Positive
- ConsistencyScore™
- 100
- consistent
Supporting studies: Based on 5 studies
View evidenceIncluded in these evidence collections
Curated evidence collections and hubs this study is part of.
CGM Time in Range Evidence Hub
All studies measuring CGM Time in Range
8 studies
outcome_hubMeasures CGM Time in Range as a key outcome.
Insulin Delivery Systems Evidence Hub
All studies on Insulin Delivery Systems
8 studies
intervention_hubContributes to Insulin Delivery Systems evidence base.
HbA1c Evidence Hub
All studies measuring HbA1c
5 studies
outcome_hubMeasures HbA1c as a key outcome.
Explore more in Evidence Explorer
Jump to pre-filtered views in Evidence Explorer.
All studies on Hybrid closed-loop system and Time in range
Intervention: Hybrid closed-loop systemOutcome: Time in range
8 results
All studies on Hybrid closed-loop system and HbA1c
Intervention: Hybrid closed-loop systemOutcome: HbA1c
5 results
All studies on Hybrid closed-loop system
Intervention: Hybrid closed-loop system
8 results
All studies measuring Time in range
Outcome: Time in range
8 results
All studies measuring HbA1c
Outcome: HbA1c
5 results
Questions answered by this study
Generated from the study's connected evidence using Evidence Intelligence™.
Does Insulin Delivery Systems improve cgm time in range?
Strong Evidence
Insulin Delivery Systems may improve CGM Time in Range.
ConsistencyScore™: Results are generally consistent across studies.
Ranked evidence signals
- 1
Time in range
EvidenceScore™ Strong | EvidenceScore™ 81.0 | strong positive | ConsistencyScore™ Consistent | 1 study
- 2
Time above range
EvidenceScore™ Moderate | EvidenceScore™ 68.4 | strong positive | ConsistencyScore™ Consistent | 1 study
- 3
Time below range
EvidenceScore™ Moderate | EvidenceScore™ 64.6 | moderate positive | ConsistencyScore™ Generally Consistent | 1 study
Why this answer: This answer is based on 17 supporting studies with generally consistent results and a positive effect signal.
Limitations
- Population details are unavailable.
Does Insulin Delivery Systems improve HbA1c?
Strong Evidence
Insulin Delivery Systems appears to improve HbA1c.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
- 1
HbA1c
EvidenceScore™ Strong | EvidenceScore™ 80.2 | strong positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on 13 supporting studies with consistent results and a positive effect signal.
Limitations
- Population details are unavailable.
Does Insulin Delivery Systems improve glucose variability?
Strong Evidence
Insulin Delivery Systems may improve Glucose Variability.
ConsistencyScore™: Results are generally consistent across studies.
Ranked evidence signals
- 1
Glucose variability
EvidenceScore™ Moderate | EvidenceScore™ 69.4 | moderate positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on 7 supporting studies with generally consistent results and a positive effect signal.
Limitations
- Population details are unavailable.
Does Insulin Delivery Systems improve fasting glucose?
Strong Evidence
Insulin Delivery Systems appears to improve Fasting Glucose.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
- 1
Blood glucose
EvidenceScore™ Moderate | EvidenceScore™ 67.6 | strong positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on 5 supporting studies with consistent results and a positive effect signal.
Limitations
- Population details are unavailable.
Next steps
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Closed-loop therapy may improve sleep quality in young people with T1DAutomated insulin-glucagon delivery reduces hypoglycemia riskClosed-loop therapy enhances glycemic control in type 2 diabetes.AHCL therapy improves glucose levels but increases diabetes distress in youthHybrid closed-loop artificial pancreas system improves blood sugar control better than insulin injections in hospitalized type 1 diabetes
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