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

Roche

Status: Completed

Conditions: Diabetes Mellitus Type 1

Treatments: Device: Comparator insulin pump; Device: Accu-Chek Spirit Insulin Pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772356

05/0377-Basal

RD000559

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

A

Experimental group

Treatment:

Device: Accu-Chek Spirit Insulin Pump

B

Active Comparator group

Treatment:

Device: Comparator insulin pump