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

This study has been completed.
Sponsor:
Information provided by:
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00501072
First received: July 12, 2007
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
Device: Real-Time Continuous Glucose monitoring System (RT-CGMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • Clinical effectiveness: percentage of time spent in euglycaemia [ Time Frame: 3-6 days ]

Secondary Outcome Measures:
  • Clinical effectiveness: Percentage of time spent in hypoglycaemia and hyperglycaemia. [ Time Frame: 3-6 days ]
  • Safety: incidence of adverse effects [ Time Frame: 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 ]

Enrollment: 12
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501072

Locations
Netherlands
Diabetes Outpatient Clinic, Isala clinics
Zwolle, Netherlands, 800 GK
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
Principal Investigator: Henk J Bilo, MD PhD, FRCP Isala Clinics, Diabetes Centre and University Medical Center Groningen
  More Information

No publications provided by Medical Research Foundation, The Netherlands

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00501072     History of Changes
Other Study ID Numbers: 07.0644, NL12530.075.06
Study First Received: July 12, 2007
Last Updated: April 8, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Medical Research Foundation, The Netherlands:
hyperglycemia
hypoglycemia
glucose variability
insulin infusion system; implantable insulin pump
continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014