Diabetes Mellitus
Conditions
Keywords
Diabetes, SMBG, Insulin calculator
Brief summary
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.
Interventions
DEVICEADC blood glucose meter
Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.
DEVICEComparator blood glucose meter
Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.
DEVICEADC blood glucose meter with insulin calculator active
Subjects used the FreeStyle InsuLinx with the insulin calculator activated.
Sponsors
Abbott Diabetes Care
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months; * Age 18 yrs and above; * Regularly testing SMBG 3 or more times per day; * Willingness to test at least 4 times per day.
Exclusion criteria
* Know to require a bolus injection of more than 50U in a single dose; * Has previously used either the InsuLinx or assigned comparison meter; * Participated in structured diabetes management training in the last 6 months * Is currently on an insulin pump; * Has concomitant disease that, in the Investigator's opinion, may compromise patient safety; * Is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management; * Female subject who is pregnant or planning to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. | 25 days | Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preference Questionnaire (Insulin Calculator Not Activated) | 25 days (results recorded after the two 7 day periods) | Result for the question: The meter the subject would change to |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 179 subjects were enrolled on this study, 164 completed the study.
Pre-assignment details
One subject was excluded due to not meeting all inclusion criteria, one subject withdrew before randomisation.
Participants by arm
| Arm | Count |
|---|---|
| Per Protocol Population Subjects who completed the study. | 164 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| ADC With Calculator (10 Days) | Physician Decision | 1 | 1 |
| ADC With Calculator (10 Days) | Protocol Violation | 0 | 1 |
| ADC With Calculator (10 Days) | Withdrawal by Subject | 2 | 0 |
| First BG Meter System (7 Days) | Adverse Event | 0 | 2 |
| First BG Meter System (7 Days) | Withdrawal by Subject | 0 | 1 |
| Second BG Meter System (7 Days) | Adverse Event | 1 | 1 |
| Second BG Meter System (7 Days) | Lost to Follow-up | 1 | 0 |
| Second BG Meter System (7 Days) | Physician Decision | 0 | 1 |
| Second BG Meter System (7 Days) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Per Protocol Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 145 Participants |
| Age, Continuous | 48.8 years STANDARD_DEVIATION 13 |
| Region of Enrollment United Kingdom | 164 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 83 Participants |
| Type of Diabetes Type 1 | 128 participants |
| Type of Diabetes Type 2 | 36 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 178 | 0 / 178 | 0 / 169 |
| serious Total, serious adverse events | 2 / 177 | 0 / 177 | 1 / 169 |
Outcome results
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.
Time frame: 25 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Per Protocol Population | Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. | 125 participants |
p-value: <0.0001Binomial test
Secondary
Preference Questionnaire (Insulin Calculator Not Activated)
Result for the question: The meter the subject would change to
Time frame: 25 days (results recorded after the two 7 day periods)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per Protocol Population | Preference Questionnaire (Insulin Calculator Not Activated) | Subject would change to FreeStyle InsuLinx | 98 participants |
| Per Protocol Population | Preference Questionnaire (Insulin Calculator Not Activated) | Subject would change to a comparison meter | 32 participants |
| Per Protocol Population | Preference Questionnaire (Insulin Calculator Not Activated) | Not likely to change / not sure / missing answer | 34 participants |