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| Tracking Information | |||||
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| First Received Date ICMJE | April 16, 2007 | ||||
| Last Updated Date | May 27, 2008 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Compare glycemic control between insulins Aspart and Lispro 24 to 100 hours after line change [ Time Frame: 24 to 100 hours after last pump infusion line change ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Compare glycemic control between insulins Aspart and Lispro 24 to 100 hours after line change | ||||
| Change History | Complete list of historical versions of study NCT00461331 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Insulins Aspart and Lispro in Insulin Pumps | ||||
| Official Title ICMJE | A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps | ||||
| Brief Summary | The purpose of the study is to study compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump. |
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| Detailed Description | Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations. One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS)and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol (glycomark) make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines. The different variables will be compared between the two insulins using a paired t test.
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Either Insulin Aspart or Lispro | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | May 2008 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| 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 ID ICMJE | NCT00461331 | ||||
| Responsible Party | Vivian Fonseca, MD, Tulane University Health Sciences Center | ||||
| Study ID Numbers ICMJE | F-0215 | ||||
| Study Sponsor ICMJE | Tulane University Health Sciences Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Tulane University Health Sciences Center | ||||
| Verification Date | December 2007 | ||||
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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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