NCT00772356

Brief Summary

This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
Last Updated

March 3, 2016

Status Verified

June 1, 2010

Enrollment Period

4 months

First QC Date

October 13, 2008

Last Update Submit

March 1, 2016

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

  • Comparison of glucose infusion rate necessary to keep blood glucose constant

    Throughout study

Secondary Outcomes (1)

  • Serum insulin and free fatty acid levels

    Throughout study

Study Arms (2)

A

EXPERIMENTAL
Device: Accu-Chek Spirit Insulin Pump

B

ACTIVE COMPARATOR
Device: Comparator insulin pump

Interventions

Accu-Chek Spirit Insulin PumpDEVICE
A
Comparator insulin pumpDEVICE
B

Eligibility Criteria

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

You may qualify if:

  • Male patients 18-65 years of age
  • Type I diabetes mellitus
  • Currently on continuous subcutaneous insulin infusion therapy

You may not qualify if:

  • Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months
  • Use of systemic corticoids in last 3 months
  • Treatment with medication known to interfere with glucose metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, 41460, 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

  • Bettina Dr. Petersen

    Roche Diagnostics GmbH

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 13, 2008

First Posted

October 15, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 3, 2016

Record last verified: 2010-06

Locations

DE(1)