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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT02600845

Run by

Hoffmann-La Roche

People needed

122

Starts

2015-12-30

Expected to finish

2017-02-20

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Huntington Beach, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Ocean Springs, Mississippi, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Pottstown, Pennsylvania, United States
• Study site — Bristol, Tennessee, United States
• Study site — Plano, Texas, United States

Full record on ClinicalTrials.gov

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