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The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Subjects will use a FreeStyle InsuLinx blood glucose meter during the study |
|
| Control | Other | Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle InsuLinx | Device | FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in Target Blood Glucose Range | Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL) | Day 1-15 compared with Day 60-74 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol). | Day 1 compared with Day 74 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Michaela Diamant | VU University Medical Centre (VUMC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Zentrum Mergentheim | Bad Mergentheim | 97980 | Germany | |||
| Diabetes-Zentrum für Kinder und Jugendliche |
A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | FreeStyle InsuLinx | Subjects will use a FreeStyle InsuLinx blood glucose meter during the study FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature. |
| FG001 | FreeStyle Freedom Lite | Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study. FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | FreeStyle InsuLinx | Subjects will use a FreeStyle InsuLinx blood glucose meter during the study FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature. |
| BG001 | FreeStyle Freedom Lite |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Target Blood Glucose Range | Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL) | One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation. | Posted | Mean | Standard Deviation | hours per day | Day 1-15 compared with Day 60-74 |
|
Adverse events collected from enrolment to completion by last subject (up to 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 | FreeStyle InsuLinx | Subjects will use a FreeStyle InsuLinx blood glucose meter during the study FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Middle ear effusion | Ear and labyrinth disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Snr Director, Clinical Development & Regulatory Affairs | Abbott Diabetes Care | 01993 863164 | joe.bugler@abbott.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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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| FreeStyle Freedom Lite | Device | FreeStyle Freedom Lite is a blood glucose meter |
|
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. |
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied). The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test. |
| Day 60 compared to day 1 |
| Hanover |
| 30173 |
| Germany |
| Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm | Ulm | D-89081 | Germany |
| VU University Medical Centre (VUMC) | Amsterdam | 1007 MB | Netherlands |
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study. FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| Screening HbA1c | Mean | Standard Deviation | mmol/mol |
|
| Screening HbA1c | Mean | Standard Deviation | Percentage of Glycosylated Haemoglobin |
|
| FreeStyle Freedom Lite |
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study. FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter |
|
|
|
| Secondary | HbA1c | HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol). | One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation. | Posted | Mean | Standard Deviation | Percentage of Glycosylated Haemoglobin | Day 1 compared with Day 74 |
|
|
|
|
| Secondary | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. | The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied). The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test. | One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | Day 60 compared to day 1 |
|
|
|
|
| 3 |
| 33 |
| 8 |
| 33 |
| EG001 | FreeStyle Freedom Lite | Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study. FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter | 2 | 16 | 4 | 16 |
| Gingiva abcess | Infections and infestations | Non-systematic Assessment |
|
| Fractured Metacarpus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sensor tip | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Haematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypoglycaemia | Endocrine disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Mean Difference (Final Values) |
| -0.09 |
| Standard Deviation |
| 0.51 |
| No |
| Superiority or Other |
| Treatment Satisfaction |
|
| t-test, 2 sided |
| 0.0960 |
| Mean Difference (Final Values) |
| -0.31 |
| Standard Deviation |
| 1.03 |
| 2-Sided |
| 95 |
| -0.68 |
| 0.06 |
| No |
| Superiority or Other |
| Treatment Satisfaction | t-test, 2 sided | 0.0007 | Mean Difference (Final Values) | 4.36 | Standard Deviation | 6.53 | 2-Sided | 95 | 2.01 | 6.71 | No | Superiority or Other |