FDA grants 510(k) clearance for SweetSpot Diabetes Data Management Service

SweetSpot Diabetes Care, Inc. announced today it has received 510(k) clearance from the United States Food & Drug Administration (FDA) for the SweetSpot Diabetes Data Management Service which helps health care providers and patients see, understand and use blood glucose meter data to diagnose and manage diabetes.

"We spoke to many patients and health care providers to develop this service," said Christopher Logan, Chief Executive Officer of SweetSpot Diabetes Care, Inc.  "Patients want something that works with all their devices that's as easy as an ATM. Health care providers want technology sophisticated enough that it's almost invisible - reports show up where and when they are needed and the data flow is fully automated. With the SweetSpot Diabetes Data Management Service more clinics will gain the benefit of comprehensive analysis of patient blood glucose data. We are thrilled to be cleared to market this to clinics."

The SweetSpot Diabetes Data Management Service automates the workflow of blood glucose data from device retrieval through data processing, analysis, report generation and delivery into clinical settings and electronic records. A cloud-based platform is the backbone - enabling secure interactions with all formats of patient devices and communications with all sites in the evolving diabetes care setting landscape.

Vendor-Neutral Device Retrieval

Data from most common blood glucose meters can be retrieved during a step-by-step session at a physical kiosk or through a web-based application. Patient information and clinical history may be collected at the same time. For patients with multiple glucometers, data from all devices will be merged into one set.

Backend Processing and Analytics

The SweetSpot Diabetes Data Management Service performs multiple data processing steps - checking the validity and completeness of data from devices. Various analyses are run when data is saved or updated within the system including time-series statistical analysis and pattern-recognition. Cohort analysis is also undertaken, looking at groupings and relationships such as gender, age, diabetes type, etc.

Immediate Report Generation and Delivery

As soon as patient glucose data is retrieved, the SweetSpot Diabetes Data Management Service generates a report and pushes it straight to clinic printers and/or electronic health record systems. Patients can also receive reports via a secure link.

Comprehensive Visualizations of Critical Data

Reports contain visualizations of daily and weekly glucose levels; display testing frequency; and provide statistical summaries and measures of glucose variability.

Reports may also compare a patient's data with their cohort and can be customized by a clinic to best support their providers and patients.

"Blood glucose data is important for effective diabetes management," said Adam Greene, SweetSpot Founder and Chief Technology Officer.  "We are excited to offer a service that makes it practical for any clinic to access their patients' data and use that information to improve care."