ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
NCT ID: NCT02600845
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2015-12-30
2017-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ACCU-CHEK
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.
ACCU-CHEK
ACCU-CHEK Connect Diabetes Management System contains ACCU-CHEK Aviva Connect Blood Glucose Monitoring System, ACCU-CHEK Connect Diabetes Management App, and ACCU-CHEK Connect Online Diabetes Management System.
Interventions
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ACCU-CHEK
ACCU-CHEK Connect Diabetes Management System contains ACCU-CHEK Aviva Connect Blood Glucose Monitoring System, ACCU-CHEK Connect Diabetes Management App, and ACCU-CHEK Connect Online Diabetes Management System.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Roche Diabetes Care
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Lena Borsa
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Montgomery, Alabama, United States
Huntington Beach, California, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Ocean Springs, Mississippi, United States
Lincoln, Nebraska, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Pottstown, Pennsylvania, United States
Bristol, Tennessee, United States
Plano, Texas, United States
Countries
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References
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Mora P, Buskirk A, Lyden M, Parkin CG, Borsa L, Petersen B. Use of a Novel, Remotely Connected Diabetes Management System Is Associated with Increased Treatment Satisfaction, Reduced Diabetes Distress, and Improved Glycemic Control in Individuals with Insulin-Treated Diabetes: First Results from the Personal Diabetes Management Study. Diabetes Technol Ther. 2017 Dec;19(12):715-722. doi: 10.1089/dia.2017.0206. Epub 2017 Oct 13.
Other Identifiers
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RD002206
Identifier Type: -
Identifier Source: org_study_id