Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump (IP_RT-CGMS)

April 8, 2008 updated by: Medical Research Foundation, The Netherlands

Use of a Real Time Continuous Glucose Monitoring System (RT-CGMS) in Type 1 Diabetes Patients on Continuous Intraperitoneal Insulin Infusion (CIPII. A Feasibility Study

To investigate the effectiveness and safety of a Real Time Continuous Glucose Monitoring System (RT-CGMS in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Strict glycaemic control reduces risk of complications and improves quality of life in patients with type 1 diabetes mellitus. Real Time Continuous Glucose Monitoring System (RT-CGMS) is a novel system which can provide patients and health care professionals with real time information about the blood glucose level without the need for multiple invasive measurements. Furthermore, with continuous monitoring it is possible to identify trends in glycaemic profiles. Its effectiveness and safety have never been tested in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.

Objective: To investigate the effectiveness and safety of the RT-CGMS in patients treated with intraperitoneal continuous insulin infusion (CIPII).

Study design: Open label, randomized cross-over, single-center controlled trial.

Study population: Patients on CIPII. Intervention: There are 3 study phases. In the Baseline phase, all patients will have the RT-CGMS blinded so that no information on blood glucose values measured and stored by the RT-CGMS will be available to care-givers, investigators or patients during this study period. Randomization will determine the sequence of blinded and unblinded RT-CGMS in the 2nd and 3rd phase. When the RT-CGMS is not blinded, the system will alert whenever a glucose level falls below or rises above preset values. Sensor values are not intended to be used directly for making therapy adjustments. Whenever a value is below or above the preset value, the blood glucose level will be measured using a blood glucose meter and therapy adjustments based on this value will be done according to protocol.

Study endpoints: Primary: Percentage of time spent in euglycaemia. Secondary: percentage of time spent in hypoglycaemia and hyperglycaemia, incidence and severity of hypoglycaemia (as measured with SMBG), incidence of adverse effects, number of measurements of blood glucose (SMBG) performed, number of adjustments of insulin therapy, patient satisfaction, agreement of paired SMBG and RT-CGMS measurements.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zwolle, Netherlands, 800 GK
        • Diabetes Outpatient Clinic, Isala clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients on CIPII and treated in the Isala Clinics, Zwolle, The Netherlands
  • Age >18 years
  • Uncontrolled diabetes mellitus type 1

Exclusion Criteria:

  • Failure to obtain informed consent
  • Any condition prevention proper handling of the device, for instance hearing impairment or visual impairment
  • Known allergy to sensor (parts)
  • Currently pregnant or trying to conceive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open
Real-Time Continuous Glucose monitoring System (RT-CGMS) with alarm setting active and ability to view glucose trend profiles
Device: Real-Time Continuous Glucose monitoring System (RT-CGMS)
No Intervention: Blind
RT-CGMS is applied without alarm setting and without the ability to watch glucose trend profiles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical effectiveness: percentage of time spent in euglycaemia
Time Frame: 3-6 days
3-6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical effectiveness: Percentage of time spent in hypoglycaemia and hyperglycaemia.
Time Frame: 3-6 days
3-6 days
Safety: incidence of adverse effects
Time Frame: ca. 30 days
ca. 30 days
Incidence of hypoglycaemia; Number of SMBG performed, Number of adjustments of insulin therapy, Patient satisfaction, agreement of paired SMBG and RT-CGMS measurements.
Time Frame: 3-6 -30 days
3-6 -30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Foundation, The Netherlands

Investigators

  • Principal Investigator: Henk J Bilo, MD PhD, FRCP, Isala Clinics, Diabetes Centre and University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 12, 2007

First Posted (Estimate)

July 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 11, 2008

Last Update Submitted That Met QC Criteria

April 8, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.0644
  • NL12530.075.06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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