Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump (IP_RT-CGMS)
Diabetes Mellitus, Type 1
Device: Real-Time Continuous Glucose monitoring System (RT-CGMS)
|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|
- Clinical effectiveness: percentage of time spent in euglycaemia [ Time Frame: 3-6 days ]
- 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 ]
|Study Start Date:||November 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501072
|Diabetes Outpatient Clinic, Isala clinics|
|Zwolle, Netherlands, 800 GK|
|Principal Investigator:||Henk J Bilo, MD PhD, FRCP||Isala Clinics, Diabetes Centre and University Medical Center Groningen|