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

Hoffmann-La Roche12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Type 1

Interventions

Accu-Chek Spirit Insulin PumpDEVICE

One basal rate

Accu-Chek Spirit Insulin PumpDEVICE

Multiple basal rates

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Ulm, Germany

Outcomes

Primary Outcomes

Pilot trial to establish endpoints such as "time within target range of a composite fasting day"

Time frame: Study duration

Secondary Outcomes

AUC, MAGE, HbA1c, body weight change

Time frame: Study duration

Data from ClinicalTrials.gov

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