RCT Evaluating Novel Sensing Technology in Type 2 Diabetes Rev 1.0
Research type
Research Study
Full title
Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes.
IRAS ID
143616
Contact name
Gerry Rayman
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Research summary
A randomised controlled study to evaluate how effective the Abbott sensor based glucose monitoring system (Sensor) is in improving glycaemic control (blood sugar control) in the self-management of patients with Type 2 diabetes as compared to Self Monitoring Blood Glucose (SMBG) testing. The Abbott sensor based glucose monitoring system is indicated for measuring glucose (sugar) levels in interstitial (tissue) fluid. It combines comprehensive data and enhanced data availability with a significantly diminished patient burden.
Subjects will have Type 2 diabetes with a HbA1c1 (test showing average level of blood glucose over 3 months) of ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) and treated by daily injections of insulin or continuous subcutaneous insulin infusion (injection of insulin under the skin) for 6 months before enrolment. Subjects must regularly perform SMBG testing as part of their current self-management. 210 subjects are required to obtain a minimum of 165 subjects. There are two treatment groups, the SMBG arm (control) requiring 55 subjects and Sensor arm (intervention) requiring 110 subjects. Subjects are planned to be recruited over 30 sites in the European Union.
The study 4 phases;
1) Screening and enrolment: Patients will provide informed consent and HbA1c samples taken.
2) Baseline and randomisation: At day one eligibility is confirmed and for 14 days all subjects will wear a masked Abbott Sensor Based Glucose Monitoring System. Following the masked phase at day 15 they will be randomised to the treatment or control arm.
3) Treatment Period: This is for 208 days.
4) Open access phase: Following the treatment phase the intervention arm subjects will have continued access to the device for an observation period of 180 days.
Throughout the study the subjects will attend for a maximum of 9 visits and receive 3 telephone calls. Adverse events and assessment of outcome measures will continue to me assessed at these visits.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0449
Date of REC Opinion
2 Jan 2014
REC opinion
Favourable Opinion