Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.
Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC, Then Comparator, Then ADC With Calculator | Experimental | Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. |
|
| Comparator, Then ADC, Then ADC With Calculator | Experimental | Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC blood glucose meter | Device | Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. | Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method. | 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Preference Questionnaire (Insulin Calculator Not Activated) | Result for the question: "The meter the subject would change to" | 25 days (results recorded after the two 7 day periods) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shenaz Ramtoola | Royal Blackburn Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tameside Hospital NHS Foundation Trust | Ashton-under-Lyne | OL6 9RW | United Kingdom | |||
| Ayr Hospital |
One subject was excluded due to not meeting all inclusion criteria, one subject withdrew before randomisation.
A total of 179 subjects were enrolled on this study, 164 completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ADC, Then Comparator, Then ADC With Calculator | Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First BG Meter System (7 Days) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Comparator blood glucose meter | Device | Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter. |
|
|
| ADC blood glucose meter with insulin calculator active | Device | Subjects used the FreeStyle InsuLinx with the insulin calculator activated. |
|
|
| Ayr |
| KA6 6DX |
| United Kingdom |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Royal Blackburn Hospital | Blackburn | BB2 7PL | United Kingdom |
| North Manchester Diabetes Centre | Crumpsall | M8 5RB | United Kingdom |
| Ipswich Hospital NHS Trust | Ipswich | IP4 5PD | United Kingdom |
| Greenwood & Sneinton Family Medical Centre | Nottingham | NG3 7DQ | United Kingdom |
| Comparator, Then ADC, Then ADC With Calculator |
Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Second BG Meter System (7 Days) |
|
|
| ADC With Calculator (10 Days) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Per Protocol Population | Subjects who completed the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Type of Diabetes | Number | participants |
|
| 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 | Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. | Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method. | A comparator blood glucose meter was used for 7 days and a FreeStyle InsuLinx for 7 days (insulin calculator inactive). For the last 10 days a FreeStyle InsuLinx with the insulin calculator activated was used. Each subject was assigned one of the three competitor systems. Subjects had not previously used any study systems. Analysis per protocol. | Posted | Number | participants | 25 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Preference Questionnaire (Insulin Calculator Not Activated) | Result for the question: "The meter the subject would change to" | Subjects used a comparator blood glucose meter for 7 days and a FreeStyle InsuLinx meter for 7 days (insulin calculator deactivated). Subjects then completed a preference questionnaire. Each subject was assigned one of the three competitor systems. Subjects had not previously used either study device. Analysis per protocol. | Posted | Number | participants | 25 days (results recorded after the two 7 day periods) |
|
|
Adverse events collected from enrolment to completion by last subject (up to 2 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADC Blood Glucose Meter | ADC blood glucose meter for 7 days with the insulin calculator not activated. | 2 | 177 | 0 | 178 | ||
| EG001 | Comparator Blood Glucose Meter | Comparator blood glucose meter for 7 days. | 0 | 177 | 0 | 178 | ||
| EG002 | ADC Blood Glucose Meter With Calculator | ADC blood glucose meter for 10 days with the insulin calculator active. | 1 | 169 | 0 | 169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Admitted with severe abdominal pain following hysterectomy |
| |
| Hypoglycaemia | Endocrine disorders | Non-systematic Assessment | Hypoglycaemia leading to seizure, not related to study or device. |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Vomiting - admitted to hospital for less than 24 hrs. |
|
Not provided
Not provided
| 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 |
Not provided
Not provided
| Physician Decision |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
|