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To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 01 | Experimental | Subjects use new LifeScan provided BGMS for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifeScan's new BGMS | Device | LifeScan new Blood Glucose Monitoring System (BGMS) |
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| Measure | Description | Time Frame |
|---|---|---|
| A1c change from baseline after 12 weeks | A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control | 12 weeks |
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Inclusion Criteria Summary:
Exclusion Criteria Summary:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mike Grady | Contact | 01463 721000 | MGRADY@lifescan.com | |
| Kirsty Macleod | Contact | kmacleod@lifescan.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Recruiting | Edinburgh | Lothian | EH16 4SA | United Kingdom |
Device being used in the study is CE marked and will be used as intended therefore risk is minimal. What? Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
When? Beginning 9 months and ending 36 months following article publication. With whom? Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available from our archive but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found by reaching out to the study contact listed. What other documents will be available?Abbreviated CSR may be provided upon request and assessment by the company.
Up to 12 months post study completion.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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| 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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| Highland Diabetes Institute | Recruiting | Inverness | IV2 3JH | United Kingdom |
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