Comparison · NCT01369069-sae
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: serious adverse events. Trial comparisons, record NCT01369069-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01369069-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.36 | 0.322 | 0.4 | wilson | |
| Risk in group 2 | 0.347 | 0.309 | 0.387 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0124 | -0.0428 | 0.0674 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.886 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.829 | 1.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL than on Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | 80.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL | The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.~IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target. | 209 | 581 | EG000 |
| Group 2 | Sub Q Insulin to Keep Glucose Less Than 180 mg/dL | This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL~Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL. | 198 | 570 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Non-serious adverse events were assessed and reported through the treatment period (up to 72 hours). Serious adverse events were reported throughout the study period (randomization through end of study; end of study was 90 days post randomization or earlier if a participant died or withdrew consent).
Source ClinicalTrials.gov
Trial
- Title
- Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
- NCT number
- NCT01369069
- Phases
- PHASE3
- Conditions
- Acute Ischemic Stroke, Diabetes, Hyperglycemia
- Interventions
- IV insulin to maintain target glucose concentration of 80-130 mg/dL, Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
- Lead sponsor
- University of Virginia
- Results first posted
- 2019-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01369069?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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