Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump
NCT ID: NCT00501072
Last Updated: 2008-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2007-11-30
2008-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Open
Real-Time Continuous Glucose monitoring System (RT-CGMS) with alarm setting active and ability to view glucose trend profiles
Real-Time Continuous Glucose monitoring System (RT-CGMS)
Blind
RT-CGMS is applied without alarm setting and without the ability to watch glucose trend profiles
No interventions assigned to this group
Interventions
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Real-Time Continuous Glucose monitoring System (RT-CGMS)
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* Uncontrolled diabetes mellitus type 1
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical Research Foundation, The Netherlands
OTHER
Principal Investigators
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Henk J Bilo, MD PhD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Isala Clinics, Diabetes Centre and University Medical Center Groningen
Locations
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Diabetes Outpatient Clinic, Isala clinics
Zwolle, , Netherlands
Countries
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References
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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.
Other Identifiers
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NL12530.075.06
Identifier Type: -
Identifier Source: secondary_id
07.0644
Identifier Type: -
Identifier Source: org_study_id