Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump
IP_RT-CGMS
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
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedApril 11, 2008
April 1, 2008
5 months
July 12, 2007
April 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical effectiveness: percentage of time spent in euglycaemia
3-6 days
Secondary Outcomes (3)
Clinical effectiveness: Percentage of time spent in hypoglycaemia and hyperglycaemia.
3-6 days
Safety: incidence of adverse effects
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.
3-6 -30 days
Study Arms (2)
Open
EXPERIMENTALReal-Time Continuous Glucose monitoring System (RT-CGMS) with alarm setting active and ability to view glucose trend profiles
Blind
NO INTERVENTIONRT-CGMS is applied without alarm setting and without the ability to watch glucose trend profiles
Interventions
Eligibility Criteria
You may qualify if:
- Patients on CIPII and treated in the Isala Clinics, Zwolle, The Netherlands
- Age \>18 years
- Uncontrolled diabetes mellitus type 1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes Outpatient Clinic, Isala clinics
Zwolle, 800 GK, Netherlands
Related Publications (1)
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.
PMID: 19425877DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henk J Bilo, MD PhD, FRCP
Isala Clinics, Diabetes Centre and University Medical Center Groningen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 12, 2007
First Posted
July 13, 2007
Study Start
November 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 11, 2008
Record last verified: 2008-04