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To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM - intervention arm | Experimental | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. |
|
| SMBG - Control arm | Active Comparator | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Navigator | Device | Masked CGM day 1 to 15, unmasked CGM days 15 to 100 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes. | Day 86 to 100 compared to Day 1 to 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm. | Days 86 to 100 intervention arm compared to control arm |
| Glucose Standard Deviation (SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramzi Ajjan | St James Hospital, Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayr Hospital | Ayr | Ayrshire | KA6 6DX | United Kingdom | ||
| Tameside Hospital NHS Foundation Trust |
A total of 105 subjects consented and enrolled into the study. Eighteen of these withdrew before randomisation or failed screening. Eighty-seven (87) subjects were randomised and 79 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM - Intervention Arm - Type 1 Diabetes | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard SMBG |
| Device |
Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
|
| Day 86 to 100 compared to day 1 to 15 |
| HbA1c (mmol/Mol) | Day 100 compared to day 1 |
| HbA1c | Day 100 compared to day 1 |
| Ashton-under-Lyne |
| OL6 9RW |
| United Kingdom |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Birmingham Heartlands Hospital, Diabetes Clinic | City and Borough of Birmingham | B9 5SS | United Kingdom |
| University Hospital of North Durham | Durham | DH1 5TW | United Kingdom |
| Ipswich Hospital NHS Trust | Ipswich | IP4 5PD | United Kingdom |
| St James Hospital, | Leeds | LS9 7TF | United Kingdom |
| Rotherham General Hospital | Rotherham | S60 2UD | United Kingdom |
| Diabetes Centre, New Cross Hospital, | Wolverhampton | WV10 0QP | United Kingdom |
| SMBG - Control Arm - Type 1 Diabetes |
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
| FG002 | CGM - Intervention Arm - Type 2 Diabetes | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 |
| FG003 | SMBG - Control Arm - Type 2 Diabetes | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM - Intervention Arm - Type 1 Diabetes | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 |
| BG001 | SMBG - Control Arm - Type 1 Diabetes | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
| BG002 | CGM - Intervention Arm - Type 2 Diabetes | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 |
| BG003 | SMBG - Control Arm - Type 2 Diabetes | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline HbA1c | Mean | Standard Deviation | mmol/mol |
| |||||||||||||||
| Baseline HbA1c | Mean | Standard Deviation | % |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time in Range | Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes. | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | hours per day | Day 86 to 100 compared to Day 1 to 15 |
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| Secondary | Time in Range | Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm. | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | hours per day | Days 86 to 100 intervention arm compared to control arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glucose Standard Deviation (SD) | Posted | Mean | Standard Deviation | mmol/L | Day 86 to 100 compared to day 1 to 15 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c (mmol/Mol) | Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier. | Posted | Mean | Standard Deviation | mmol/mol | Day 100 compared to day 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c | Analysis performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | Percent | Day 100 compared to day 1 |
|
Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
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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 | CGM - Intervention Arm - Type 1 Diabetes | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 | 1 | 29 | 13 | 29 | ||
| EG001 | SMBG - Control Arm - Type 1 Diabetes | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100. | 0 | 13 | 7 | 13 | ||
| EG002 | CGM - Intervention Arm - Type 2 Diabetes | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100 | 0 | 30 | 17 | 30 | ||
| EG003 | SMBG - Control Arm - Type 2 Diabetes | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100. | 1 | 15 | 8 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycaemia | Endocrine disorders | Non-systematic Assessment | Not device or study related. |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not device or study related. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Endocrine disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Sensor tip | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sickness | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Infection - general | General disorders | Non-systematic Assessment |
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| Allergic reaction | General disorders | Non-systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Infection - renal | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Foot pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dental | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Snr Director, Clinical Development & 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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| Male |
|
| Final |
|
| 0.0427 |
| Mean Difference (Final Values) |
| 1.4 |
| Standard Deviation |
| 3.5 |
| 2-Sided |
| 95 |
| 0.05 |
| 2.73 |
| No |
| Superiority or Other |
| OG003 | SMBG - Control Arm - Type 2 Diabetes | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
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Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
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| OG003 |
| SMBG - Control Arm - Type 2 Diabetes |
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
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Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 |
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