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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:11/8/2017
Start Date:December 30, 2015
End Date:February 20, 2017

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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
We found this trial at
11
sites
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Bristol, TN
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Atlanta, GA
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Huntington Beach, California 92646
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Huntington Beach, CA
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from
Lincoln, NE
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from
Macon, GA
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from
Montgomery, AL
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Ocean Springs, Mississippi 39564
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Ocean Springs, MS
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Plano, TX
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Pottstown, PA
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from
Raleigh, NC
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Wilmington, North Carolina 28401
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Wilmington, NC
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