Last updated September 10, 2026
Key finding
Dysglycemia or diabetes developed in 87 participants (46 receiving oral insulin and 41 receiving placebo; hazard ratio 1.07; 95% CI 0.66–1.73; P = 0.74)
This study evaluated the effects of high-dose oral insulin in children with Stage 1 Type 1 Diabetes. It found no significant difference in progression to dysglycemia or immune response compared to placebo.
Quick read
The essential study design details in one scan.
EvidenceScore™
Moderate
Study type
RCTs
Follow-up
Long-Term (1–5 y)
Risk of bias
Some Concerns
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Plain-language summary
A plain-language read of the study’s main message and where it applies.
Study focus
This study evaluated the effects of high-dose oral insulin in children with Stage 1 Type 1 Diabetes. It found no significant difference in progression to dysglycemia or immune response compared to placebo.
Understanding the effectiveness of treatments for early-stage Type 1 Diabetes is crucial for managing the disease and preventing its progression. This study suggests that high-dose oral insulin may not provide the expected benefits, highlighting the need for further research into alternative interventions.
The study had a relatively small sample size. Results may not be generalizable beyond the studied population. Potential confounding factors were not fully accounted for.
Published in
Publication details and source links for this paper.
Anette-Gabriele Z, Ali A, Stefanie A, et al. High-Dose Oral Insulin in Children with Stage 1 Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2026;49(5):746-754. doi:10.2337/dc25-2818
Dysglycemia developed in 87 participants, with 46 in the oral insulin group and 41 in the placebo group (hazard ratio 1.07, P = 0.74).
Increased immune response to insulin was observed in 11 (25%) of 44 participants in the oral insulin group versus 13 (31%) of 42 in the placebo group (P = 0.63).
Evidence network
Understand where this research contributes within the broader evidence network.
This study contributes evidence to Oral insulin and Glycemic control comparison to commercial AID systems, Mean arterial pressure reduction.
This study contributes evidence to
Primary intervention
Oral insulin
Primary outcomes
Evidence topics
Primary intervention
Intervention and outcome relationships this study adds to the evidence network.
Editorial context
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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.
1
Related topics
2
Evidence pairs
140
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Evidence topic
Contributes evidence
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Primary evidence
Evidence topic
matched_outcome
Core evidence
The primary outcomes reported in this study.
Oral insulin → Glycemic control comparison to commercial AID systems
Oral insulin → Glycemic control comparison to commercial AID systems
Oral insulin → Mean arterial pressure reduction
Oral insulin → Mean arterial pressure reduction
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Relationships organized using the Dediabetes Evidence Intelligence™ framework.
This study contributes to evidence on Oral insulin and Glycemic control comparison to commercial AID systems, Oral insulin and Mean arterial pressure reduction.
This study contributes to the evidence on the following intervention-outcome relationships.
Curated evidence collections and hubs this study is part of.
All studies measuring Glycemic control comparison to commercial AID systems
Measures Glycemic control comparison to commercial AID systems as a key outcome.
All studies measuring Mean arterial pressure reduction
Measures Mean arterial pressure reduction as a key outcome.
All studies on Oral insulin
Contributes to Oral insulin evidence base.
Latest published studies
Published within the last 2 years.
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1 results
1 results
1 results
1 results
1 results
Generated from the study's connected evidence using Evidence Intelligence™.
Current evidence does not show a clear benefit of Oral insulin for glycemic control comparison to commercial aid systems.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Glycemic control comparison to commercial AID systems
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
Current evidence does not show a clear reduction in mean arterial pressure reduction with Oral insulin.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Mean arterial pressure reduction
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
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