Clinical trial NCT02600845: ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
Official title: ACCU-CHEK Connect Personal Diabetes Management Study (PDM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Diabetes Care
First posted: 2015-11-09
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range
timeFrame: Baseline, Week 24
measure: Change From Baseline to Week 24 in Mean Blood Glucose Level
timeFrame: Baseline, Week 24
measure: Change From Baseline to Week 24 in Glycemic Variability
timeFrame: Baseline, Week 24
measure: Incidence of Hypoglycemia
timeFrame: Baseline, Weeks 12 and 24
measure: Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24
timeFrame: Week 24
measure: Percent of Follow-Up Visits With Sufficient SMBG Data
timeFrame: Up to Week 24
measure: Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Percentage of Blood Glucose Tagged Data
timeFrame: Weeks 12 and 24
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Huntington Beach
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Ocean Springs
country: United States
state: Mississippi
city: Lincoln
country: United States
state: Nebraska
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Pottstown
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Plano
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Lena Borsa
role: STUDY_DIRECTOR
References:
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.