Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate

Roche

Status: Completed

Conditions: Diabetes Mellitus Type 1

Treatments: Device: Accu-Chek Spirit Insulin Pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569452

RD000278

DMS-01-CIRCADIAN-01

Details and patient eligibility

About

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 circadian '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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

A

Experimental group

Treatment:

Device: Accu-Chek Spirit Insulin Pump

Device: Accu-Chek Spirit Insulin Pump

B

Experimental group

Treatment:

Device: Accu-Chek Spirit Insulin Pump

Device: Accu-Chek Spirit Insulin Pump