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

Study Overview
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Brief Summary
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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.

Official Title
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ACCU-CHEK Connect Personal Diabetes Management Study (PDM)

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: ACCU-CHEK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACCU-CHEK<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Weeks 12 and 24 | 
| 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). | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Weeks 12 and 24 | 
| 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. | Week 24 | 
| 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. | Up to Week 24 | 
| 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. | Baseline, Weeks 12 and 24 | 
| 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. | Baseline, Weeks 12 and 24 | 
| 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. | Weeks 12 and 24 |