Trial Information

Summary: Starting Basal Rate Profiles Used in Continuous Subcutaneous Insulin Infusion.

Status: Completed

Protocol Number: DMS-01-CIRCADIAN-01

Sponsor:

Company Division: Diagnostic

Official Scientific Title: Comparison of basal (fasting) glycemic control in type 1 diabetic patients with CSII achieved by the circadian slide ruler scale or flat basal rate.

Brief Summary: This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by carcadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.

Study Phase: N/A

Study Design / Study Details:

• Purpose:
• Allocation: Randomized
• Masking: Open Label
• Control:
• Assignment:
• Endpoints:

Study Type:

Condition: Diabetes Mellitus, Type 1

Intervention Type: Device

Intervention Name: Accu-Chek Spirit insulin pump

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2006

Trial Registration Date: 12/04/2007

Date Last Updated: 12/18/2007

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:58:02 PM