Clinical trial NCT00461331: Comparison of Insulins Aspart and Lispro in Insulin Pumps
Official title: A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Glycemic control
Continuous subcutaneous insulin infusion
Continuous glucose monitoring system
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to 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.

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 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 1,5-anhydroglucitol.
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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change
timeFrame: 24 to 100 hours after last pump infusion line change
Secondary outcomes:
measure: Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place
timeFrame: 48 to 100 hours after keeping the same pump infusion line in place
measure: Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place
timeFrame: Between 48, 72 and 96 hours after the last pump infusion line change
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Clinical Translational Unit - Tulane School of Medicine
state: Louisiana
Study officials:
affiliation: Tulane Universtiy Health Sciences Center
name: Vivian A Fonseca, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: