Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 set placement effect blood sugar control if the infusion set is in place for longer then 72-96 hours

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joslin Diabetes Center
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.