| Trial ID: | L2145 |
| Source ID: | NCT00461331
|
| Associated Drug: |
Insulin Aspart
|
| Title: |
Comparison of Insulins Aspart and Lispro in Insulin Pumps
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00461331/results
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin Aspart|DRUG: Insulin Lispro
|
| Outcome Measures: |
Primary: Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change, For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level \>300 mg/dL., 24 to 100 hours after last pump infusion line change | Secondary: Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place, Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods., 48 to 100 hours after keeping the same pump infusion line in place|Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place, Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods., Between 48, 72 and 96 hours after the last pump infusion line change
|
| Sponsor/Collaborators: |
Sponsor: Tulane University Health Sciences Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2004-10
|
| Completion Date: |
2008-08
|
| Results First Posted: |
2011-05-19
|
| Last Update Posted: |
2021-01-08
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| Locations: |
Clinical Translational Unit - Tulane School of Medicine, New Orleans, Louisiana, 70112, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00461331
|
