A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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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

CROSSOVER

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

B

Group Type ACTIVE_COMPARATOR

Comparator insulin pump

Intervention Type DEVICE

Interventions

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Accu-Chek Spirit Insulin Pump

Intervention Type DEVICE

Comparator insulin pump

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No