NCT00569452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
Last Updated

March 3, 2016

Status Verified

June 1, 2010

Enrollment Period

4 months

First QC Date

December 6, 2007

Last Update Submit

March 1, 2016

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

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

    Study duration

Secondary Outcomes (1)

  • AUC, MAGE, HbA1c, body weight change

    Study duration

Study Arms (2)

A

EXPERIMENTAL
Device: Accu-Chek Spirit Insulin Pump

B

EXPERIMENTAL
Device: Accu-Chek Spirit Insulin Pump

Interventions

Accu-Chek Spirit Insulin PumpDEVICE

One basal rate

A

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \>= 18 years of age
  • Type 1 diabetes
  • Diabetic for \>2 years, and treated with CSII for \>= 3 months
  • HbA1c \<=8.5%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Andreas Buhr

    Disetronic Medical Systems AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

January 1, 2006

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 3, 2016

Record last verified: 2010-06

Locations

DE(1)