Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump (IP_RT-CGMS)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Real-Time Continuous Glucose monitoring System (RT-CGMS)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring hyperglycemia, hypoglycemia, glucose variability, insulin infusion system; implantable insulin pump, continuous glucose monitoring
Eligibility 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
Sites / Locations
- Diabetes Outpatient Clinic, Isala clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Open
Blind
Arm Description
Real-Time Continuous Glucose monitoring System (RT-CGMS) with alarm setting active and ability to view glucose trend profiles
RT-CGMS is applied without alarm setting and without the ability to watch glucose trend profiles
Outcomes
Primary Outcome Measures
Clinical effectiveness: percentage of time spent in euglycaemia
Secondary Outcome Measures
Clinical effectiveness: Percentage of time spent in hypoglycaemia and hyperglycaemia.
Safety: incidence of adverse effects
Incidence of hypoglycaemia; Number of SMBG performed, Number of adjustments of insulin therapy, Patient satisfaction, agreement of paired SMBG and RT-CGMS measurements.
Full Information
NCT ID
NCT00501072
First Posted
July 12, 2007
Last Updated
April 8, 2008
Sponsor
Medical Research Foundation, The Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT00501072
Brief Title
Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump
Acronym
IP_RT-CGMS
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Research Foundation, The Netherlands
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
hyperglycemia, hypoglycemia, glucose variability, insulin infusion system; implantable insulin pump, continuous glucose monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open
Arm Type
Experimental
Arm Description
Real-Time Continuous Glucose monitoring System (RT-CGMS) with alarm setting active and ability to view glucose trend profiles
Arm Title
Blind
Arm Type
No Intervention
Arm Description
RT-CGMS is applied without alarm setting and without the ability to watch glucose trend profiles
Intervention Type
Device
Intervention Name(s)
Real-Time Continuous Glucose monitoring System (RT-CGMS)
Primary Outcome Measure Information:
Title
Clinical effectiveness: percentage of time spent in euglycaemia
Time Frame
3-6 days
Secondary Outcome Measure Information:
Title
Clinical effectiveness: Percentage of time spent in hypoglycaemia and hyperglycaemia.
Time Frame
3-6 days
Title
Safety: incidence of adverse effects
Time Frame
ca. 30 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk J Bilo, MD PhD, FRCP
Organizational Affiliation
Isala Clinics, Diabetes Centre and University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Outpatient Clinic, Isala clinics
City
Zwolle
ZIP/Postal Code
800 GK
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19425877
Citation
Logtenberg SJ, Kleefstra N, Groenier KH, Gans RO, Bilo HJ. Use of short-term real-time continuous glucose monitoring in type 1 diabetes patients on continuous intraperitoneal insulin infusion: a feasibility study. Diabetes Technol Ther. 2009 May;11(5):293-9. doi: 10.1089/dia.2008.0088.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump
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