NCT02600845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

November 6, 2015

Results QC Date

August 25, 2017

Last Update Submit

October 6, 2017

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 24

Secondary Outcomes (11)

  • Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score

    Baseline, Week 24

  • Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24

    Baseline, Weeks 12 and 24

  • Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range

    Baseline, Week 24

  • Change From Baseline to Week 24 in Mean Blood Glucose Level

    Baseline, Week 24

  • Change From Baseline to Week 24 in Glycemic Variability

    Baseline, Week 24

  • +6 more secondary outcomes

Study Arms (1)

ACCU-CHEK

EXPERIMENTAL

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

Interventions

ACCU-CHEKDEVICE

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.

ACCU-CHEK

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Montgomery, Alabama, 36105, United States

Location

Unknown Facility

Huntington Beach, California, 92648, United States

Location

Unknown Facility

Atlanta, Georgia, 30318, United States

Location

Unknown Facility

Macon, Georgia, 31210, United States

Location

Unknown Facility

Ocean Springs, Mississippi, 39564, United States

Location

Unknown Facility

Lincoln, Nebraska, 68521, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Wilmington, North Carolina, 28401, United States

Location

Unknown Facility

Pottstown, Pennsylvania, 19464, United States

Location

Unknown Facility

Bristol, Tennessee, 37620, United States

Location

Unknown Facility

Plano, Texas, 75075, United States

Location

Related Publications (1)

  • 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.

    PMID: 29027812DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
1-800-821-8590

Study Officials

  • Lena Borsa

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 9, 2015

Study Start

December 30, 2015

Primary Completion

September 29, 2016

Study Completion

February 20, 2017

Last Updated

November 6, 2017

Results First Posted

November 6, 2017

Record last verified: 2017-10

Locations

US(11)