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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACCU-CHEK
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACCU-CHEK

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at 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
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
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
Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL).
Change From Baseline to Week 24 in Mean Blood Glucose Level
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
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
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
Competency was defined as appropriate response to high and low glucose values.
Percent of Follow-Up Visits With Sufficient SMBG Data
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
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
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
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.

Full Information

First Posted
November 6, 2015
Last Updated
October 6, 2017
Sponsor
Hoffmann-La Roche
Collaborators
Roche Diabetes Care GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02600845
Brief Title
ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
Official Title
ACCU-CHEK Connect Personal Diabetes Management Study (PDM)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 30, 2015 (Actual)
Primary Completion Date
September 29, 2016 (Actual)
Study Completion Date
February 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Roche Diabetes Care GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACCU-CHEK
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ACCU-CHEK
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score
Description
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.
Time Frame
Baseline, Week 24
Title
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Description
Assessment of HbA1c is an indicator of long-term control of diabetes.
Time Frame
Baseline, Weeks 12 and 24
Title
Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range
Description
Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL).
Time Frame
Baseline, Week 24
Title
Change From Baseline to Week 24 in Mean Blood Glucose Level
Description
Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes.
Time Frame
Baseline, Week 24
Title
Change From Baseline to Week 24 in Glycemic Variability
Description
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.
Time Frame
Baseline, Week 24
Title
Incidence of Hypoglycemia
Description
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.
Time Frame
Baseline, Weeks 12 and 24
Title
Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24
Description
Competency was defined as appropriate response to high and low glucose values.
Time Frame
Week 24
Title
Percent of Follow-Up Visits With Sufficient SMBG Data
Description
Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments.
Time Frame
Up to Week 24
Title
Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24
Description
An increase in the number of blood glucose checks indicates more glycemic control.
Time Frame
Baseline, Weeks 12 and 24
Title
Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24
Description
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.
Time Frame
Baseline, Weeks 12 and 24
Title
Percentage of Blood Glucose Tagged Data
Description
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.
Time Frame
Weeks 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Borsa
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36105
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68521
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29027812
Citation
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.
Results Reference
derived

Learn more about this trial

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

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