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

Abbott

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: Sensor Based Glucose Monitoring System; Device: Standard Blood Glucose Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT02082184

ADC-CI-APO-12018

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Sensor Based Glucose Monitoring System

Experimental group

Description:

Standard system use for 6 months. Followed by open access to the device for 6 months.

Treatment:

Device: Sensor Based Glucose Monitoring System

Standard Blood Glucose Monitoring

Active Comparator group

Description:

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Treatment:

Device: Standard Blood Glucose Monitoring