Status:
TERMINATED
Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine: 1. whether there is a difference between insulin aspart and insulin lispro in continuous insulin pump therapy 2. whether duration of the insulin infusion se...
Detailed Description
Insulin instability in pump infusion systems can result in unexplained hyperglycemia in patients on continuous subcutaneous insulin infusion (CSII) therapy. We have noted that some pump patients devel...
Eligibility Criteria
Inclusion
- Type 1 diabetes treated with CSII at least 3 months.
- Males and females, \> 18 years but \< 75 years old.
- Hemoglobin A1c ≤ 8.0 % at measurement taken at week 0 (screening visit).
- Duration of diabetes ≥ 12 months.
- Willingness to perform self-blood glucose monitoring several times/day.
Exclusion
- Previous insulin precipitation in pump infusion catheters.
- Daily insulin requirements \> 25% of pump reservoir capacity. (This would preclude the subject from using the pump infusion system for more than 3 days).
- Use of an insulin pump that does not have a downloadable record of basal and bolus doses.
- Known or suspected allergy to trial products.
- Pregnancy, breast-feeding, intention to become pregnant or inadequate contraception measures.
- Known or suspected alcohol or drug abuse.
- Impaired renal function with creatinine ≥ 1.7 mg/dl.
- Pronounced catheter site scarring.
- Chronic use of drugs that may influence glycemic control (e.g. steroids).
- Any other significant concomitant disease that would interfere with participation in and completion of the trial.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00428207
Start Date
February 1 2007
End Date
August 1 2008
Last Update
May 30 2017
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215