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Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

NCT00286962 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2008-04-11

No results posted yet for this study

Summary

The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

MIP 2007C implantable insulin pump

Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c

DEVICE

continuous subcutaneous insulin infusion (CSII) or MDI

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medical Research Foundation, The Netherlands

    lead OTHER

Principal Investigators

  • Henk J Bilo, MD, PhD · Isala Clinics, medical research foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00286962 on ClinicalTrials.gov