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

NCT ID: NCT00569452

Last Updated: 2016-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Accu-Chek Spirit Insulin Pump

Intervention Type DEVICE

One basal rate

B

Group Type EXPERIMENTAL

Accu-Chek Spirit Insulin Pump

Intervention Type DEVICE

Multiple basal rates

Interventions

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Accu-Chek Spirit Insulin Pump

One basal rate

Intervention Type DEVICE

Accu-Chek Spirit Insulin Pump

Multiple basal rates

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Buhr

Role: STUDY_DIRECTOR

Disetronic Medical Systems AG

Locations

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Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DMS-01-CIRCADIAN-01

Identifier Type: -

Identifier Source: secondary_id

RD000278

Identifier Type: -

Identifier Source: org_study_id

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