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Comparison · NCT01369069-e2e3ac8f

IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Number of Participants With a Favorable Modified Rankin Scale (Yes/No)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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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: Number of Participants With a Favorable Modified Rankin Scale (Yes/No). Trial comparisons, record NCT01369069-e2e3ac8f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01369069-e2e3ac8f

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2050.1740.24wilson
Risk in group 20.2160.1840.251wilson
Risk difference, group 1 minus group 2-0.011-0.05810.0361newcombe hybrid score
Risk ratio, group 1 over group 20.9490.7591.19log
Odds ratio, group 1 over group 20.9360.7051.24log
Number needed to treat, for one fewer participant with the outcome 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/dL91.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1IV 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.
119581OG000
Group 2Sub 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.
123570OG001

Outcome

Type
PRIMARY
Title
Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
Description
Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.
Time frame
90 days (-14/+30 days)
Population

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

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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