Real-world evidence showing improved glycemic control using a Bluetooth®-connected blood glucose meter with a mobile diabetes app

3 Mar 2023

Written by Linda Essex

Diabetes Editorials News Real-world evidence

A study of real-world data gathered from 144,000 people with diabetes using a smart blood glucose meter together with a mobile diabetes app demonstrates improved percentages of blood glucose readings in-range and reduced hyperglycemia.

A new real-world data (RWD) study in blood glucose monitoring for diabetes carried out by global healthcare technology company LifeScan has been published in the Journal of Diabetes Science and Technology. The study comprised a retrospective analysis of RWD gathered through LifeScan’s OneTouch Verio Flex^® (OTVF) smart blood glucose meter (BGM) and OneTouch Reveal^® (OTR) diabetes management mobile app. The data demonstrated sustained clinically significant improvements in blood glucose (BG) readings in-range, with proportionate and clinically meaningful reductions in hyperglycemic readings in people with diabetes (PWD) types 1 and 2 who started using the smart BGM together with the mobile app, generating real-world evidence (RWE) for combining the use of two devices to improve glycemic control. The full article is called Improved glycemic control using a Bluetooth®-connected blood glucose meter and a mobile diabetes app: real-world evidence from over 144,000 people with diabetes.

Multiple studies have demonstrated improved glycemic control with structured or continuous BG monitoring in PWD, however harnessing the opportunities created from the wealth of data gathered requires PWDs and their health care providers (HCP) to interpret and act upon the available insights. LifeScan is a global leader in technology for BG monitoring and management — more than 20 million people worldwide use LifeScan’s OneTouch brand products to manage their diabetes. The researchers conducted this largest ever study of a BGM connected by Bluetooth® to a mobile diabetes app used in tandem in order to demonstrate that real world glycemic control is improved by combining the use of the two devices. It was hypothesized that the OTR app could augment the value of the OTVF BGM by playing a key role in aggregating, interpreting, and presenting insights to both PWD and HCP.

LifeScan have amassed de-identified data uploaded from OneTouch brand products used by over 144,000 PWD across 27 countries. For this study the researchers identified subjects registered between January 2012 and August 2022 who used both OTVF and OTR, and who had performed at least 180 readings over the first 180 days of using OTR. Data from the first 14 days using the OTVF meter with the OTR app were compared with the last 14 days prior to the 180-day endpoint. The dataset covered 16,591 people with type one diabetes (PwT1D) and 97,119 PwT2D. The anonymized data included: diabetes type; BG readings categorized as below, within or above in-range (70-180 mg/dL); and analytics of OTR usage, such as time spent, number of sessions, and screens viewed in the app.

The retrospective data analysis showed that amongst PWD with at least 180 readings within the 180-day timeframe of using the OTR app with the OTVF meter, 35% of PwT1D and 40% of PwT2D improved their BG readings in range (RIR) by >10 percentage points. Overall, improved glycemic control was observed as an increase of +6.1 percentage points (54.5% to 60.6%) of RIR in T1D, and +11.9 percentage points of RIR (68.2% to 80.1%) in T2Ds. Reduced hyperglycemic readings (>180 mg/dL) altered by −6.6 percentage points (40.5% to 33.9%) in T1D, and −12.0 percentage points (30.3% to 18.3%) in T2D. Mean BG reduced by −11.4 and −19.5 mg/dL from baseline to 180 days in PwT1D or PwT2D respectively, with no clinically meaningful changes in percentage of hypoglycemic readings.

Investigating the effect of app engagement on glycemia, the analysis showed that PwT1D spending 2–4 sessions or 10–20 minutes per week on the app improved RIR by +5.1 and 7.0 respectively. PwT2D spending spending 2–4 sessions or 10–20 minutes per week on the app improved RIR by +11.6 and 12.0 respectively. The data also showed that a cohort spending as few as 10–20 minutes per week in the app improved RIR by +7.0 percentage points in T1D and by +12.0 percentage points in T2D, and reduced hyperglycemic readings by -7.7 percentage points in T1D and -12.1 percentage points in T2Ds.

“These findings, from the largest patient population we have studied to date, offer real-world evidence that people with diabetes can further increase their health benefits by using their Bluetooth connected blood glucose meter in tandem with a diabetes app on their smartphone” asserted study co-author Elizabeth Holt, Head of Global Medical, Clinical and Safety at LifeScan. “The overwhelming majority, approximately 95%, of people with diabetes who monitor their blood glucose rely on cost-effective blood glucose monitoring with a blood glucose meter. It is critical that we continue to research how they can get the most health benefits from their blood glucose meter readings”.

These 180-day findings expand on the results from a 90-day study first presented by the authors at the American Diabetes Association 82nd Scientific Sessions in June 2022. The researchers are planning future analysis of the impact of a direct digital connection between PWD and HCP. HCPs who registered to use the professional web version of OTR were able to view BG levels in real time from PWD who had consented to share their data, enabling those HCPs to more efficiently perform telemedicine between scheduled consultations and taking the synergy between the devices one step further.