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ART42490-004_rev-A 10:30am 04-May-22
Skin Interaction
Based on the examination of 101 study participants, the following incidence of skin
issues were observed. All skin issues were reported to be mild or moderate in
severity.
Bleeding – 3.0% of participants
Edema – 1.0% of participants
Erythema – 5.0% of participants
Induration – 2.0% of participants
Itching – 1.0% of participants
Expected Clinical Benefits
Complications as a result of diabetes mellitus (including, but not limited to:
diabetic retinopathy, diabetic nephropathy) are well documented.
Self-monitoring
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of blood glucose (SMBG) by patients has revolutionised management of diabetes.
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Using glucose monitoring devices patients with diabetes can work to achieve and
maintain specific glycaemia goals. Given the results of the Diabetes Control and
Complications Trial (DCCT)
and other studies, there is broad consensus on the
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health benefits of normal or near-normal blood glucose levels and on the
importance, especially in insulin-treated patients, of glucose monitoring devices in
treatment e"orts designed to achieve these glycaemic goals. Based principally on
the DCCT results, experts recommend that most individuals with diabetes should
attempt to achieve and maintain blood glucose levels as close to normal as is
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