Diabetes Mellitus, Type 1IP_RT-CGMSNCT00501072
Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump
A study testing Real-Time Continuous Glucose monitoring System (RT-CGMS) in people with Diabetes Mellitus, Type 1, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Real-Time Continuous Glucose monitoring System (RT-CGMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on CIPII and treated in the Isala Clinics, Zwolle, The Netherlands
- Age >18 years
- Uncontrolled diabetes mellitus type 1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Diabetes Outpatient Clinic, Isala clinics
Zwolle, 800 GK
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Real-Time Continuous Glucose monitoring System (RT-CGMS)
- Keywords
- hyperglycemia, hypoglycemia, glucose variability, insulin infusion system; implantable insulin pump, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Continuous Glucose monitoring System (RT-CGMS)Device
| Study group | Role | What they receive |
|---|---|---|
| Open | Experimental | Real-Time Continuous Glucose monitoring System (RT-CGMS) with alarm setting active and ability to view glucose trend profiles Receives: Device: Real-Time Continuous Glucose monitoring System (RT-CGMS) |
| Blind | No intervention | RT-CGMS is applied without alarm setting and without the ability to watch glucose trend profiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness: percentage of time spent in euglycaemia
Measured: 3-6 days
Secondary outcomes (3)
Clinical effectiveness: Percentage of time spent in hypoglycaemia and hyperglycaemia.
Measured: 3-6 days
Safety: incidence of adverse effects
Measured: 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.
Measured: 3-6 -30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Investigators
- Henk J Bilo, MD PhD, FRCP, Principal investigator, Isala Clinics, Diabetes Centre and University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501072
- Sponsor's protocol ID
- 07.0644
- Other IDs
- NL12530.075.06
- Acronym
- IP_RT-CGMS
- Status last verified
- Apr 2008
- First submitted
- 12 Jul 2007
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19425877
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00501072
- Acronym / sponsor ID
- IP_RT-CGMS / 07.0644
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- hyperglycemia, hypoglycemia, glucose variability, insulin infusion system; implantable insulin pump, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open | Experimental | Device: Real-Time Continuous Glucose monitoring System (RT-CGMS)Real-Time Continuous Glucose monitoring System (RT-CGMS) with alarm setting active and ability to view glucose trend profiles |
| Blind | No intervention | –RT-CGMS is applied without alarm setting and without the ability to watch glucose trend profiles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients on CIPII and treated in the Isala Clinics, Zwolle, The Netherlands
- Age >18 years
- Uncontrolled diabetes mellitus type 1
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time Continuous Glucose monitoring System (RT-CGMS) | Device | Open |
Primary outcome
Clinical effectiveness: percentage of time spent in euglycaemia
Time frame: 3-6 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
- Derived from this study: PubMed 19425877Logtenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk J Bilo, MD PhD, FRCP principal investigator
Isala Clinics, Diabetes Centre and University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Continuous Glucose monitoring System (RT-CGMS) in people with Diabetes Mellitus, Type 1, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness: percentage of time spent in euglycaemia (time frame: 3-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2008.