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

Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes

To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.

Inclusion Criteria:

1. Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry.

2. Their insulin management must be one of the following;

   1. an injection regimen of prandial insulin at least once daily,
   2. or, prandial insulin at least once daily plus basal insulin at least once daily,
   3. or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the study.

3. HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study.

4. 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.

5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System.

6. In the Investigator's opinion the subject is proactive and therefore willing to modify their diabetes management

7. Aged 18 years or over.

Exclusion Criteria:

1. Insulin regimen consists entirely of basal or includes bi-phasic insulin.
2. Subject is currently prescribed animal insulin.
3. Subject is currently prescribed steroid therapy or is likely to require steroid therapy for any acute or chronic condition during the study.
4. Has known allergy to medical grade adhesives.
5. Currently participating in another device or drug study that could affect glucose measurements or glucose management.
6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months.
7. Is planning to use a CGM device at any time during the study.
8. Total daily dose of insulin (TDD) is >1.75iu/kg at entry to the study.
9. A female subject who is pregnant or planning to become pregnant within the study duration.
10. Currently receiving dialysis treatment or planning to receive dialysis during the study.
11. Has experienced an acute myocardial infarction within previous 6 months.
12. 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.
13. Has a pacemaker or any other neuro stimulators.
14. Has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months.
15. Has experienced any episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the previous 6 months.
16. In the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.