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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569452

Enrollment

Registered

2007-12-07

Start date

2006-01-31

Completion date

2006-05-31

Last updated

2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 1

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 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.

Interventions

DEVICEAccu-Chek Spirit Insulin Pump

One basal rate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Pilot trial to establish endpoints such as time within target range of a composite fasting day	Study duration

Secondary

Measure	Time frame
AUC, MAGE, HbA1c, body weight change	Study duration

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026