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

This study has been completed.
Sponsor:
Collaborator:
Roche Diabetes Care GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02600845
First received: November 6, 2015
Last updated: May 3, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 1
Device: ACCU-CHEK AVIVA CONNECT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: ACCU-CHEK Connect Personal Diabetes Management Study (PDM)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Treatment Satisfaction: Change from Baseline to Week 24 in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures:
  • Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score [ Time Frame: Baseline, Week 24 ]
  • Participants Preference for the ACCU-CHEK Connect Process as Assessed by Healthcare Providers (HCP) Questionnaire [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 and 24 [ Time Frame: Baseline, Week 12, Week 24 ]
  • Change From Baseline to Week 24 in Percentage Glucose Target Range [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline to Week 24 in Mean Blood Glucose Level [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline to Week 24 in Glycemic Variability [ Time Frame: Baseline, Week 24 ]
  • Percentage of Participants With Hypoglycemia [ Time Frame: 24 Weeks ]
  • Change From Baseline to Week 24 in Participants Self-monitoring of Blood Glucose (SMBG) Data Problem Solving Skill [ Time Frame: Baseline, Week 24 ]
  • Clinician/staff Preference for the ACCU-CHEK Connect Process as Assessed by HCP Questionnaire [ Time Frame: Week 24 ]
  • Impact of Structured Diabetes Data on Healthcare Practitioner's Informed Decision Regarding Participants Therapy Adjustment as Assessed by HCP Questionnaire [ Time Frame: 24 Weeks ]

Enrollment: 125
Actual Study Start Date: December 30, 2015
Study Completion Date: February 20, 2017
Primary Completion Date: September 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACCU-CHEK
All participants will utilize ACCU-CHEK Connect Diabetes Management System containing three primary component: 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.
Device: ACCU-CHEK AVIVA CONNECT
ACCU-CHEK Connect Diabetes Management System contains ACCU-CHEK aviva connect blood glucose monitoring system, ACCU-CHEK connect diabetes management app, ACCU-CHEK connect online diabetes management system.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02600845

Locations
United States, Alabama
Montgomery, Alabama, United States, 36105
United States, California
Huntington Beach, California, United States, 92648
United States, Georgia
Atlanta, Georgia, United States, 30318
Macon, Georgia, United States, 31210
United States, Mississippi
Ocean Springs, Mississippi, United States, 39564
United States, Nebraska
Lincoln, Nebraska, United States, 68521
United States, North Carolina
Raleigh, North Carolina, United States, 27609
Wilmington, North Carolina, United States, 28401
United States, Pennsylvania
Pottstown, Pennsylvania, United States, 19464
United States, South Carolina
Columbia, South Carolina, United States, 29223
United States, Tennessee
Bristol, Tennessee, United States, 37620
United States, Texas
Plano, Texas, United States, 75075
Sponsors and Collaborators
Hoffmann-La Roche
Roche Diabetes Care GmbH
Investigators
Study Director: Lena Borsa Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02600845     History of Changes
Other Study ID Numbers: RD002206
Study First Received: November 6, 2015
Last Updated: May 3, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 25, 2017