Efficacy of Structured Insulin Order
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01130558
First received: May 24, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | May 24, 2010 | ||||
| Last Updated Date | May 24, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean blood Glucose [ Time Frame: 6 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Structured Insulin Order | ||||
| Official Title ICMJE | Efficacy of Structured Insulin Orders in Improving Glycemic Control | ||||
| Brief Summary | The purpose of this study is to determine whether an electronic order template for basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients with poorly controlled type 2 diabetes. |
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| Detailed Description | The study randomly assigned internal medicine residents to use an electronic insulin order template plus basal-bolus ordering education versus education only. For all patients with uncontrolled type 2 diabetes treated by these physicians, mean blood glucose, rate of hypoglycemia, and rate of sliding scale insulin use were measured. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE | Other: Diabetes Management
Using electronic insulin order template for basal-bolus insulin and education |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 128 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01130558 | ||||
| Other Study ID Numbers ICMJE | 2008P-0022131 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Enrico Cagliero, M.D., Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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