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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02600845
First Posted: November 9, 2015
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Diabetes Care GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24 [ Time Frame: Week 24 ]
    The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3='much worse now' to 3='much better now'). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only.


Secondary Outcome Measures:
  • Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score [ Time Frame: Baseline, Week 24 ]
    Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.

  • Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    Assessment of HbA1c is an indicator of long-term control of diabetes.

  • Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range [ Time Frame: Baseline, Week 24 ]
    Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL).

  • Change From Baseline to Week 24 in Mean Blood Glucose Level [ Time Frame: Baseline, Week 24 ]
    Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes.

  • Change From Baseline to Week 24 in Glycemic Variability [ Time Frame: Baseline, Week 24 ]
    Glycemic variability refers to swings in blood glucose levels. Mean glycemic variability is expressed as a standard deviation of blood glucose data. A negative number indicates a decrease in glucose variability. A positive number indicates and increase in glucose variability.

  • Incidence of Hypoglycemia [ Time Frame: Baseline, Weeks 12 and 24 ]
    A hypoglycemic reading was defined as a glucose value that fell below the 70 mg/dL level. The incidence of hypoglycemia was defined as the number of hypoglycemic readings in the interval divided by the total number of blood glucose checks in the interval.

  • Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24 [ Time Frame: Week 24 ]
    Competency was defined as appropriate response to high and low glucose values.

  • Percent of Follow-Up Visits With Sufficient SMBG Data [ Time Frame: Up to Week 24 ]
    Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments.

  • Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    An increase in the number of blood glucose checks indicates more glycemic control.

  • Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    An increase in SMBG frequency indicates more glycemic control. The average number of daily SMBG measurements per interval was calculated based on the total number of blood glucose readings recorded during the study visit interval.

  • Percentage of Blood Glucose Tagged Data [ Time Frame: Weeks 12 and 24 ]
    Tagged data specifies the timing of blood glucose recording and includes: fasting, before breakfast, after breakfast, before lunch, after lunch, before dinner, after dinner, and bedtime. The percentage of blood glucose tagged data per interval was calculated as the total number of tagged blood glucose readings during the interval divided by the total number of readings within the interval.


Enrollment: 122
Actual Study Start Date: December 30, 2015
Study Completion Date: February 20, 2017
Primary Completion Date: September 29, 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 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.
Device: 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 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
First Submitted: November 6, 2015
First Posted: November 9, 2015
Results First Submitted: August 25, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 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