ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)

ACCU-CHEK Connect Personal Diabetes Management Study (PDM)

This post-market, interventional, prospective, single arm, the United States (US) based multi-center study will assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.

Inclusion Criteria:

• Diagnosis of type 1 or type 2 diabetes for greater than or equal to (>=) 6 months
• Currently using insulin as a component of the diabetes therapy
• Allow and be able to provide self-monitoring of blood glucose (SMBG) data at least 1 month prior to study start
• SMBG frequency as confirmed by site SMBG data download of participants meter(s): Basal insulin treated participants - SMBG >=5 times per week and Multiple dose insulin participants - SMBG >=2 times per day
• Glycosylated hemoglobin (HbA1c) of >=7.5 percentage (per local laboratory obtained less than or equal to [<= 3] months of Baseline)
• Able to read and write in English language
• Currently using a Smartphone and have experience with downloading at minimum one application
• Smartphone compatibility; must be able to download the ACCU-CHEK Connect system application accordingly
• Naive to the ACCU-CHEK Connect system
• Willing to comply with study procedures

Exclusion Criteria:

• Treatment with insulin pump therapy
• Any use of continuous glucose monitoring (CGM) to manage their diabetes during the course of the study
• Visually impaired
• Women who are pregnant, lactating or planning to become pregnant during the study period
• Diagnosed with any clinically significant condition (for example anemia, major organ system disease, infections, psychosis or cognitive impairment)
• Participant requires chronic steroid in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
• Participant is the investigator or any sub-investigator, general practitioner, practice staff, pharmacist, research assistant or other staff or relative of those directly involved in the conduct of the study and design of the protocol