Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501072
Status:
COMPLETED
Last Update Posted:
2008-04-11
First Post:
2007-07-12
Brief Title:
Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump
Sponsor:
Medical Research Foundation The Netherlands
Organization:
Medical Research Foundation The Netherlands
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IP_RT-CGMS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL1253007506 | None | None | None |