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

Roche

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: ACCU-CHEK

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02600845

RD002206

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

ACCU-CHEK

Experimental group

Description:

All participants will utilize ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.

Treatment:

Device: ACCU-CHEK