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International Navigator Hypoglycaemia Study

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ClinicalTrials.gov Identifier: NCT00843609
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : February 5, 2010
Sponsor:
Collaborators:
Karolinska Institutet
Schneider Children's Medical Center, Israel
Information provided by:
University Medical Centre Ljubljana

Tracking Information
First Submitted Date  ICMJE February 12, 2009
First Posted Date  ICMJE February 13, 2009
Last Update Posted Date February 5, 2010
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE International Navigator Hypoglycaemia Study
Official Title  ICMJE International Navigator Hypoglycaemia Study: Evaluation of the Incidence and Duration of Hypoglycaemia Using the Freestyle Navigator® Continuous Glucose Monitoring System
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Hypoglycemia
Intervention  ICMJE Device: Navigator continuous glucose monitor (Freestyle Navigator®)
Continuous use of the Free Style Navigator for monitoring of glycemia in patients with type 1 diabetes with HbA1c below 7.5 %
Other Name: Free Style Navigator
Study Arms  ICMJE
  • Experimental: Continuous glucose monitoring
    Continuously wearing the FreeStyle Navigator continuous glucose monitor, displaying real-time glucose values and sounding alarms
    Intervention: Device: Navigator continuous glucose monitor (Freestyle Navigator®)
  • No Intervention: Control
    Using SMBG with standard routine instructions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2010)
122
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2009)
120
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   Slovenia,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00843609
Other Study ID Numbers  ICMJE INHS1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tadej Battelino, MD,PhD, Professor of pediatrics, UMC Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE
  • Karolinska Institutet
  • Schneider Children's Medical Center, Israel
Investigators  ICMJE
Principal Investigator: Tadej Battelino, Prof. UMC Ljubljana
PRS Account University Medical Centre Ljubljana
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP