Comparison · NCT01565941-c8d51188
Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Hypokalemia (<2.5 mmol/L)
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. Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Hypokalemia (<2.5 mmol/L). Trial comparisons, record NCT01565941-c8d51188. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01565941-c8d51188
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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 | 0.218 | 0.178 | 0.264 | wilson | |
| Risk in group 2 | 0.183 | 0.146 | 0.227 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0344 | -0.0251 | 0.0937 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.882 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.855 | 1.8 | log | |
| Number needed to treat, for one more participant with the outcome on Tight Glycemic Control 1 (TGC-1) than on Tight Glycemic Control 2 (TGC-2) | 29.1 | 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 | Tight Glycemic Control 1 (TGC-1) | Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL | 76 | 349 | OG000 |
| Group 2 | Tight Glycemic Control 2 (TGC-2) | Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL | 64 | 349 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Participants With Hypokalemia (<2.5 mmol/L)
- Description
Hypoglycemia will be tracked and reported according to three ranges: severe (\<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia \<2.5 mmol/L will also be tracked.
- Time frame
- Participants will be followed for the duration of ICU stay, an expected average of 8 days
- Population
Source ClinicalTrials.gov
Trial
- Title
- Heart And Lung Failure - Pediatric INsulin Titration Trial
- NCT number
- NCT01565941
- Phases
- PHASE3
- Conditions
- Heart Failure, Respiratory Failure
- Interventions
- Insulin, Insulin
- Lead sponsor
- Boston Children's Hospital
- Results first posted
- 2017-12-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01565941?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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