An interventional study of ADC blood glucose meter and Comparator blood glucose meter in Diabetes Mellitus, sponsored by Abbott Diabetes Care. Completed at 7 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-04.
Sponsored by Abbott Diabetes Care · Not applicable, Interventional, and Supportive care
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 179 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Abbott Diabetes Care is the lead sponsor of 42 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: ADC blood glucose meter · Device: Comparator blood glucose meter · Device: ADC blood glucose meter with insulin calculator active
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.
Device: ADC blood glucose meter · Device: Comparator blood glucose meter · Device: ADC blood glucose meter with insulin calculator active
Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.
Also known as: Abbott Freestyle InsuLinx
Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.
Also known as: Roche Accu-Chek Aviva Nano, Lifescan Verio Pro or, Bayer Contour USB
Subjects used the FreeStyle InsuLinx with the insulin calculator activated.
Also known as: Abbott FreeStyle InsuLinx
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
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)
A total of 179 subjects were enrolled on this study, 164 completed the study.
| Milestone | ADC, Then Comparator, Then ADC With Calculator | Comparator, Then ADC, Then ADC With Calculator |
|---|---|---|
| Started | 90 | 87 |
| Completed | 90 | 84 |
| Not completed | 0 | 3 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | ADC, Then Comparator, Then ADC With Calculator | Comparator, Then ADC, Then ADC With Calculator |
|---|---|---|
| Started | 90 | 84 |
| Completed | 88 | 81 |
| Not completed | 2 | 3 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | ADC, Then Comparator, Then ADC With Calculator | Comparator, Then ADC, Then ADC With Calculator |
|---|---|---|
| Started | 88 | 81 |
| Completed | 85 | 79 |
| Not completed | 3 | 2 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.
| participants | Per Protocol Population |
|---|---|
| Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. | 125 |
Result for the question: "The meter the subject would change to"
| participants | Per Protocol Population |
|---|---|
| Subject would change to FreeStyle InsuLinx | 98 |
| Subject would change to a comparison meter | 32 |
| Not likely to change / not sure / missing answer | 34 |
Collected over Adverse events collected from enrolment to completion by last subject (up to 2 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADC Blood Glucose Meter | — | 2/177 (1.1%) | 0/178 (0%) |
| Comparator Blood Glucose Meter | — | 0/177 (0%) | 0/178 (0%) |
| ADC Blood Glucose Meter With Calculator | — | 1/169 (0.6%) | 0/169 (0%) |
| Event | ADC Blood Glucose Meter | Comparator Blood Glucose Meter | ADC Blood Glucose Meter With Calculator |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 0/177 | 0/177 | 1/169 |
| HypoglycaemiaEndocrine disorders | 1/177 | 0/177 | 0/169 |
| VomitingGastrointestinal disorders | 1/177 | 0/177 | 0/169 |
| Age, Categorical(Participants) | Per Protocol Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 145 |
| >=65 years | 19 |
| Age, Continuous(years) | Per Protocol Population |
|---|---|
| Mean | 48.8 ± 13.0 |
| Sex: Female, Male(Participants) | Per Protocol Population |
|---|---|
| Female | 81 |
| Male | 83 |
| Region of Enrollment(participants) | Per Protocol Population |
|---|---|
| United Kingdom | 164 |
| Type of Diabetes(participants) | Per Protocol Population |
|---|---|
| Type 1 | 128 |
| Type 2 | 36 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Abbott Diabetes Care