Starting Basal Rate Profiles Used in Continuous Subcutaneous Insulin Infusion - Clinical Trials for Ketoacidosis and Diabetes

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:
Interventional

Condition: Diabetes Mellitus, Type 1

Intervention Type: Device

Intervention Name: Accu-Chek Spirit insulin pump

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

* adult patients >=18 years of age;
* type 1 diabetes;
* diabetic for >2 years, and treated with CSII for >=3 months;
* HbA1c <=8.5%.

Exclusion Criteria:

* excessive fibrosis or lipo-hypertrophy at injection or infusion sites;
* unstable chronic disease other than type 1 diabetes;
* severe hypoglycemic event within last week prior to study start;
* severe diabetic ketoacidosis within last month prior to study start.

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

Contact:
Research Site:
Located In:
Ulm, Germany, 89081
Telephone: 973-235-5000 or 800-526-6367