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Comparison of Insulins Aspart and Lispro in Insulin Pumps
This study is ongoing, but not recruiting participants.
Study NCT00461331   Information provided by Tulane University Health Sciences Center
First Received: April 16, 2007   Last Updated: May 27, 2008   History of Changes

April 16, 2007
May 27, 2008
October 2004
June 2007   (final data collection date for primary outcome measure)
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 ]
Compare glycemic control between insulins Aspart and Lispro 24 to 100 hours after line change
Complete list of historical versions of study NCT00461331 on ClinicalTrials.gov Archive Site
  • 1-Compare daily serum glycomark levels 48 to 100 hours after pump infusion line change [ Time Frame: 24 to 100 hours after the last pump infusion line change ] [ Designated as safety issue: No ]
  • 2-Compare the changes in coagulation, inflammation, protein glycation and oxidative stress 48, 72 and 96 hours after pump infusion line change [ Time Frame: 24 to 100 hours after the last pump infusion line change ] [ Designated as safety issue: No ]
  • Analysis of the pump infusion line more than 48 hours after pump infusion line change [ Time Frame: 24 to 100 hours after the last pump infusion line change ] [ Designated as safety issue: Yes ]
  • 1-Compare daily serum glycomark levels 48 to 100 hours after pump infusion line change
  • 2-Compare the changes in coagulation, inflammation, protein glycation and oxidative stress 48, 72 and 96 hours after pump infusion line change
  • 3-Analysis of the pump infusion line more than 48 hours after pump infusion line change
 
Comparison of Insulins Aspart and Lispro in Insulin Pumps
A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps

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.

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.

  1. Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum glycomark.
  2. Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared.
  3. The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control.
  4. Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study
  • Type 1 Diabetes Mellitus
  • Glycemic Control
Drug: Either Insulin Aspart or Lispro
  • Active Comparator: Either insulin Aspart or insulin Lispro were randomized to be insulin 1.
  • Active Comparator: Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
20
May 2008
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 Diabetes treated with a pump for at least 3 months

Exclusion Criteria:

  • Pregnancy
  • Plasma Creatinine > 1.2 mg/dl
  • Inability to give informed consent
  • HbA1c > 8%
  • Known or suspected hypersensitivity to trial drugs or any of their components
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00461331
Vivian Fonseca, MD, Tulane University Health Sciences Center
F-0215
Tulane University Health Sciences Center
 
Principal Investigator: Vivian A Fonseca, MD, FRCP Tulane Universtiy Health Sciences Center
Tulane University Health Sciences Center
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP