ASPIRE STUDY
Research type
Research Study
Full title
Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences (ASPIRE).
IRAS ID
180638
Contact name
Laura Ritchie
Contact email
Sponsor organisation
LifeScan Scotland Ltd a J & J Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
This is a multicentre randomized post-market clinical device study to demonstrate improved blood glucose control in subjects with type 1 and type 2 diabetes using the blood glucose monitoring system (BGMS) in combination with a Bluetooth enabled mobile phone application system over a period of 24 weeks, compared to subjects using only the BGMS.
The study will enrol approximately 142 (128 to fully complete) subjects across all UK sites, aged 18 to 70 years. It will incorporate 2 arms (intervention and control) of 71 persons per arm to run concurrently. This study protocol & application is specific for BioKinetic Europe Ltd only. BioKinetic Europe Ltd will enrol a minimum of 35 subjects.
Each person will attend the study site on up to 5 separate occasions, no overnight stays are required.
Subjects will have their existing BGMS replaced with the study BGMS for 24 weeks. The blood glucose meter has BlueTooth connectivity allowing data capture & storage on a mobile phone application (APP).
The patient can review their data on the APP which is also externally reviewed by the health care professionals (HCP) in charge of the study via web based software.
Subjects using BGMS and Mobile APP will be sent SMS text messages by the HCP and may be asked to adjust their current self-monitoring of blood glucose (SMBG), therapy and lifestyle to help their diabetes control, based on the readings. If the HCP feels that a change of the subjects’ existing diabetic therapy is needed, they will inform the subjects’ GP in writing.
Subjects using BGMs only (control group) will not receive SMS messages. Subjects will be asked to complete several surveys throughout the study.
REC name
HSC REC B
REC reference
15/NI/0078
Date of REC Opinion
20 May 2015
REC opinion
Favourable Opinion