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

  • Metabolic Disorder
  • Type 1 Diabetes Mellitus
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT02600845 RD002206

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT02600845, RD002206 Trial Identifier
      ACCU-CHEK Treatments
      Diabetes Mellitus, Type 1 Condition
      Official Title

      ACCU-CHEK Connect Personal Diabetes Management Study (PDM)

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 75 Years Age
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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