Diabetes Mellitus, Type 1NCT00843609
International Navigator Hypoglycaemia Study
A study testing Navigator continuous glucose monitor (Freestyle Navigator®) in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by University Medical Centre Ljubljana at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose Monitoring System in people with Type 1 diabetes mellitus at good glycemic control. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Hypoglycemia
- What is being tested?
- Navigator continuous glucose monitor (Freestyle Navigator®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2008to Jan 2010
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with Type 1 diabetes (> 1year since diagnosis)
- CSII or MDI
- HbA1c at inclusion < 7.5 %
- No concomitant diseases that influence metabolic control
- No current use of CGM
Who cannot join
- Subject has known allergy to medical grade adhesives
- Subject has a medical condition, which in the Investigator's opinion, may compromise patient safety
- Subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
- Subject is currently using another CGM device or has used real-time continuous glucose monitoring in the previous 4 weeks
- Subject is receiving peritoneal dialysis solutions containing icodextrin
- Female subject who is pregnant or planning to become pregnant within the planned study duration
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Slovenia1 site
UMC Ljubljana - University Children's Hospital
Ljubljana, 1000
About this study
Official title: International Navigator Hypoglycaemia Study: Evaluation of the Incidence and Duration of Hypoglycaemia Using the Freestyle Navigator® Continuous Glucose Monitoring System
The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose Monitoring System in people with Type 1 diabetes mellitus at good glycemic control. The investigators hypothesize that the access to real-time continuous glucose concentration data along with alarms will enable people with type 1 diabetes at reasonable metabolic control to reduce the time spent in hypoglycaemia.
Read the detailed description
Background:
Real-time continuous glucose monitoring is expected to allow patients to reduce glycaemic fluctuations and to improve their ability to achieve tight glycaemic control without an increase in the incidence or fear of hypoglycaemia through the availability of high fidelity real-time glucose data and alarms throughout the day. As well as in adults, this may be particularly important in both children and adolescents with type 1 diabetes mellitus (T1DM).
Study Overview:
This is a multicentre, prospective, randomised, controlled, intervention study, being conducted at 3 study centres; Ljubljana in Slovenia, Tel Aviv in Israel and Stockholm in Sweden.
The aim is to enroll 100 subjects (50 adult and 50 paediatric), but enrolling up to 120 eligible subjects to allow for dropouts. The subject population will be randomly assigned 50:50 to either the control group or intervention group.
Subjects will be asked to participate for 7 months, consisting of a one-month 'run-in' period on SMBG followed by a 6-month test period. Enrolment will take place within a 16-week period. A blood sample will be taken for centralized baseline measurement of HbA1c. To be included in the study a subject must have an HbA1c level at inclusion below 7.5 % All subjects will undergo a one-month run-in period. Each subject will be given a FreeStyle blood glucose meter and strips to perform self monitoring of blood glucose (SMBG) according to their standard glycaemic management regime, as advised by their health care professional (HCP).
Subjects will then be required to return to the clinic at the end of the run-in period to have another blood sample taken for centralized measurement of HbA1c and to be randomly assigned to Group 1 (intervention) or Group 2 (control) for the next 6-month test period.
Group 1 will be required to use the FreeStyle Navigator CGM to manage their glycaemic control, wearing individual sensors for a series of five day durations, for the next six months.
Group 2 will continue in the study for the next 6 months using SMBG to manage their glycaemic control with the FreeStyle meter and strips provided. Every second week the subject will wear a 'masked' FreeStyle Navigator sensor for 5 days. Subjects will be encouraged to alternate the days that they wear the FreeStyle Navigator sensors, so that data is obtained from days in both the week and weekend.
Subjects will return to the clinic at 3 months and 6 months (after entering the study test-phase) for centralized HbA1c measurement. Subjects (and parents of paediatric subjects) within the intervention group will also be asked to complete a subject satisfaction questionnaire on their experience with the device.
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia
- Being tested
- Navigator continuous glucose monitor (Freestyle Navigator®)
- Keywords
- diabetes mellitus, type 1, hypoglycemia, continuous glucose monitoring, HbA1c, glycemic variability
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator continuous glucose monitor (Freestyle Navigator®)Device
Also called Free Style Navigator
Continuous use of the Free Style Navigator for monitoring of glycemia in patients with type 1 diabetes with HbA1c below 7.5 %
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring | Experimental | Continuously wearing the FreeStyle Navigator continuous glucose monitor, displaying real-time glucose values and sounding alarms Receives: Device: Navigator continuous glucose monitor (Freestyle Navigator®) |
| Control | No intervention | Using SMBG with standard routine instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia).
Measured: 6 months after randomisation
Secondary outcomes (4)
No concomitant rise in HbA1c
Measured: 6 months after randomization
Glycaemic variability
Measured: 6 months after randomization
Frequency and area under the curve (AUC) of hypoglycaemia
Measured: 6 months after randomization
Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire);
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Schneider Children's Medical Center, Israel
- Investigators
- Tadej Battelino, Prof., Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843609
- Sponsor's protocol ID
- INHS1
- Status last verified
- Jun 2009
- First submitted
- 12 Feb 2009
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Navigator Hypoglycaemia Study: Evaluation of the Incidence and Duration of Hypoglycaemia Using the Freestyle Navigator® Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT00843609
- Acronym / sponsor ID
- INHS1
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia
- Keywords
- diabetes mellitus, type 1, hypoglycemia, continuous glucose monitoring, HbA1c, glycemic variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Schneider Children's Medical Center, Israel
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Feb 2009 (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.
The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose Monitoring System in people with Type 1 diabetes mellitus at good glycemic control. The investigators hypothesize that the access to real-time continuous glucose concentration data along with alarms will enable people with type 1 diabetes at reasonable metabolic control to reduce the time spent in hypoglycaemia.
Detailed description
Background:
Real-time continuous glucose monitoring is expected to allow patients to reduce glycaemic fluctuations and to improve their ability to achieve tight glycaemic control without an increase in the incidence or fear of hypoglycaemia through the availability of high fidelity real-time glucose data and alarms throughout the day. As well as in adults, this may be particularly important in both children and adolescents with type 1 diabetes mellitus (T1DM).
Study Overview:
This is a multicentre, prospective, randomised, controlled, intervention study, being conducted at 3 study centres; Ljubljana in Slovenia, Tel Aviv in Israel and Stockholm in Sweden.
The aim is to enroll 100 subjects (50 adult and 50 paediatric), but enrolling up to 120 eligible subjects to allow for dropouts. The subject population will be randomly assigned 50:50 to either the control group or intervention group.
Subjects will be asked to participate for 7 months, consisting of a one-month 'run-in' period on SMBG followed by a 6-month test period. Enrolment will take place within a 16-week period. A blood sample will be taken for centralized baseline measurement of HbA1c. To be included in the study a subject must have an HbA1c level at inclusion below 7.5 % All subjects will undergo a one-month run-in period. Each subject will be given a FreeStyle blood glucose meter and strips to perform self monitoring of blood glucose (SMBG) according to their standard glycaemic management regime, as advised by their health care professional (HCP).
Subjects will then be required to return to the clinic at the end of the run-in period to have another blood sample taken for centralized measurement of HbA1c and to be randomly assigned to Group 1 (intervention) or Group 2 (control) for the next 6-month test period.
Group 1 will be required to use the FreeStyle Navigator CGM to manage their glycaemic control, wearing individual sensors for a series of five day durations, for the next six months.
Group 2 will continue in the study for the next 6 months using SMBG to manage their glycaemic control with the FreeStyle meter and strips provided. Every second week the subject will wear a 'masked' FreeStyle Navigator sensor for 5 days. Subjects will be encouraged to alternate the days that they wear the FreeStyle Navigator sensors, so that data is obtained from days in both the week and weekend.
Subjects will return to the clinic at 3 months and 6 months (after entering the study test-phase) for centralized HbA1c measurement. Subjects (and parents of paediatric subjects) within the intervention group will also be asked to complete a subject satisfaction questionnaire on their experience with the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | Experimental | Device: Navigator continuous glucose monitor (Freestyle Navigator®)Continuously wearing the FreeStyle Navigator continuous glucose monitor, displaying real-time glucose values and sounding alarms |
| Control | No intervention | –Using SMBG with standard routine instructions |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with Type 1 diabetes (> 1year since diagnosis)
- CSII or MDI
- HbA1c at inclusion < 7.5 %
- No concomitant diseases that influence metabolic control
- No current use of CGM
Key exclusion criteria (6 listed)
- Subject has known allergy to medical grade adhesives
- Subject has a medical condition, which in the Investigator's opinion, may compromise patient safety
- Subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
- Subject is currently using another CGM device or has used real-time continuous glucose monitoring in the previous 4 weeks
- Subject is receiving peritoneal dialysis solutions containing icodextrin
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 |
|---|---|---|
| Navigator continuous glucose monitor (Freestyle Navigator®)Also: Free Style NavigatorContinuous use of the Free Style Navigator for monitoring of glycemia in patients with type 1 diabetes with HbA1c below 7.5 % | Device | Continuous glucose monitoring |
Primary outcome
Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia).
Time frame: 6 months after randomisation
4 secondary outcomes
No concomitant rise in HbA1c
Time frame: 6 months after randomization
Glycaemic variability
Time frame: 6 months after randomization
Frequency and area under the curve (AUC) of hypoglycaemia
Time frame: 6 months after randomization
Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire);
Time frame: 6 months after randomization
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 5 Feb 2010.
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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.
Tadej Battelino, Prof. principal investigator
UMC Ljubljana
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator continuous glucose monitor (Freestyle Navigator®) in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by University Medical Centre Ljubljana at 3 sites in 3 countries.
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 5 inclusion and 6 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 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Slovenia, Sweden. 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?
Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia). (time frame: 6 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2010.