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

March 1, 2016 updated by: Hoffmann-La Roche
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Device: Accu-Chek Spirit Insulin Pump
One basal rate
Device: Accu-Chek Spirit Insulin Pump
Multiple basal rates
Experimental: B
Device: Accu-Chek Spirit Insulin Pump
One basal rate
Device: Accu-Chek Spirit Insulin Pump
Multiple basal rates

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC, MAGE, HbA1c, body weight change
Time Frame: Study duration
Study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Andreas Buhr, Disetronic Medical Systems AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 7, 2007

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD000278
  • DMS-01-CIRCADIAN-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus Type 1

Clinical Trials on Accu-Chek Spirit Insulin Pump

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe