An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes

Inclusion Criteria

• Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry.
• Their insulin management must be one of the following;
• an injection regimen of prandial insulin at least once daily,
• or, prandial insulin at least once daily plus basal insulin at least once daily,
• or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the study.
• HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study.
• Reports self-testing of blood glucose levels on a regular basis equivalent to a minimum of 10 tests per week, for at least 2 months prior to study entry.
• In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System.
• In the Investigator's opinion the subject is proactive and therefore willing to modify their diabetes management
• Aged 18 years or over.

Exclusion Criteria

• Insulin regimen consists entirely of basal or includes bi-phasic insulin.
• Subject is currently prescribed animal insulin.
• Subject is currently prescribed steroid therapy or is likely to require steroid therapy for any acute or chronic condition during the study.
• Has known allergy to medical grade adhesives.
• Currently participating in another device or drug study that could affect glucose measurements or glucose management.
• Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months.
• Is planning to use a CGM device at any time during the study.
• Total daily dose of insulin (TDD) is >1.75iu/kg at entry to the study.
• A female subject who is pregnant or planning to become pregnant within the study duration.
• Currently receiving dialysis treatment or planning to receive dialysis during the study.
• Has experienced an acute myocardial infarction within previous 6 months.
• Has a concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition.
• Has a pacemaker or any other neuro stimulators.
• Has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months.
• Has experienced any episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the previous 6 months.
• In the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.