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| Name | Class |
|---|---|
| Liverpool University Hospitals NHS Foundation Trust | OTHER_GOV |
| National Heatlh Service Ayrshire and Arran | OTHER_GOV |
| NHS Lothian | OTHER_GOV |
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To demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and HbA1c.
Study Overview This is a multi-centre pilot study across 6 study sites, recruiting 50 subjects. Each subject will use a FreeStyle Navigator Continuous Glucose Monitor for a period of 20 days at the start of the study, after which their Healthcare Professionals (HCPs) may recommend changes to their glucose management based on the continuous glucose monitoring(CGM) data. Subjects will then return to self-managing their diabetes with a blood glucose meter. After 2 months, subjects will use the FreeStyle Navigator for a further 5 days and review their results and glucose management with their HCPs. Subjects will again return to self-managing their diabetes with a blood glucose meter until the end of the study, when the last FreeStyle Navigator 5 day wear is completed and HbA1c and measures of glycaemic variability are recorded.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Navigator Continuous Glucose Monitoring System | Device | Six x 5 day wears of the continuous glucose monitoring device. Two of the 6 wears will be using a masked device (1 at the start and 1 at the end of the study). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1C From Baseline to 6 Months | HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline) | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% | Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months). | Baseline and 6 months |
| Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiten Vora, MRCP | The Royal Liverpool and Broadgreen University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayr Hospital | Ayr | Ayrshire | KA6 6DX | United Kingdom | ||
| The Royal Liverpool University Hospital |
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Participants with type 1 or type 2 diabetes on Multiple Daily Injection(MDI)of insulin(3 or more injections per day)with an HbA1c of 8% or more for their last two tests were recruited at five sites across the United Kingdom. The target enrolment was 50 subjects, with the aim of completing the study with 40 subjects for statistical analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants using the FreeStyle Navigator System Intermittently. At the start and end of the study subjects wore the FreeStyle Navigator masked (without seeing continuous glucose results) for 5 days (1 sensor wear). During the study subjects used the FreeStyle Navigator fully functional (unmasked) for 2 periods. The first unmasked phase was for 2 weeks (3 sensor wears) following the baseline masked wear. The second unmasked phase was a 5 day wear at 3 months. After each unmasked phase the HCP reviewed results with the subject and changes to insulin regimen were recommended as required. For the remainder of the study a standard blood glucose meter was used for diabetes management. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| National Health Service, United Kingdom |
| OTHER_GOV |
| Cardiff and Vale University Health Board | OTHER_GOV |
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Proportion of time (hours per day) in hypoglycaemia (<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device. |
| Baseline & 6 months |
| Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked | Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase | 2 weeks following baseline & 3 months |
| Liverpool |
| Cheshire |
| L7 8XP |
| United Kingdom |
| University Hospital Aintree | Liverpool | Cheshire | L9 7AL | United Kingdom |
| Glan Clywd Hospital | Rhyl | Denbighshire | LL18 5UJ | United Kingdom |
| St. John's Hospital | Livingston | Edinburgh | EH54 6PP | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants using the FreeStyle Navigator System Intermittently |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
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| Weight | Mean | Full Range | Kg |
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| Years since diagnosis | Mean | Full Range | Years |
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| Daily Total Insulin Dosage-Basal | Mean | Full Range | Units |
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| Daily Total Insulin Dosage-Bolus | Mean | Full Range | Units |
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| Number of injections per day | Mean | Full Range | Injections |
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| Number of blood glucose measurements per day | Mean | Full Range | Tests |
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| HbA1c | Mean | Full Range | % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in HbA1C From Baseline to 6 Months | HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline) | Intention to treat analysis | Posted | Mean | Standard Deviation | HbA1c % | Baseline and 6 months |
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| Secondary | Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% | Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months). | Intention to treat analysis | Posted | Number | participants | Baseline and 6 months |
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| Secondary | Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked | Proportion of time (hours per day) in hypoglycaemia (<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device. | Analysis per protocol | Posted | Mean | Standard Deviation | Hours per day | Baseline & 6 months |
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| Secondary | Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked | Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase | Analysis per protocol 31 participants analysed in the unmasked phase 1 28 participants analysed in the unmasked phase 2 | Posted | Mean | Standard Deviation | Hours per day | 2 weeks following baseline & 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Participants using the FreeStyle Navigator System Intermittently | 3 | 32 | 3 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right iliac fossa pain | General disorders | Not device related, not related to study procedure, severity - moderate |
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| Unresolving Paronychia | Skin and subcutaneous tissue disorders | Not device related, not related to study procedure, severity - moderate |
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| Viral Meningitis | Infections and infestations | Not device related, not related to study procedure, severity - moderate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Not device related, not related to study procedure, severity - mild |
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| Abdominal pain (muscle strain) | Musculoskeletal and connective tissue disorders | Not device related, not related to study procedure, severity - moderate |
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| Broken toe | Musculoskeletal and connective tissue disorders | Not device related, not related to study procedure, severity - moderate |
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After an enrolment review recruitment was ceased on 02 Sep 11 with only 32/50 enrolled subjects. The screening/recruitment phase had been 12 weeks but was significantly extended. Only 7/32 subjects had completed 6 month HbA1c when recruitment ceased.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Global Clinical and EMEA Regulatory Affairs | Abbott Diabetes Care | 01993863164 | joe.bugler@abbott.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Time in hypoglycaemia(3.9mmol/L)unmasked phase 1 |
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| Time in hypoglycaemia(3.9mmol/L)unmasked phase 2 |
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