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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00843609
Other study ID # INHS1
Secondary ID
Status Completed
Phase N/A
First received February 12, 2009
Last updated February 4, 2010
Start date October 2008
Est. completion date January 2010

Study information

Verified date June 2009
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority Slovenia: Ministry of Health
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date January 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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 %

Locations

Country Name City State
Israel Schneider Children's Medical Center of Israel Petah Tikva
Slovenia UMC Ljubljana - University Children's Hospital Ljubljana
Sweden Karolinska Institutet Stockholm

Sponsors (3)

Lead Sponsor Collaborator
University Medical Centre Ljubljana Karolinska Institutet, Schneider Children's Medical Center, Israel

Countries where clinical trial is conducted

Israel,  Slovenia,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia). 6 months after randomisation No
Secondary No concomitant rise in HbA1c 6 months after randomization No
Secondary Glycaemic variability 6 months after randomization No
Secondary Frequency and area under the curve (AUC) of hypoglycaemia 6 months after randomization No
Secondary Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire); 6 months after randomization No
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