AzTrials
AzTrials

Diabetes Mellitus, Type 1NCT02600845

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

A study testing ACCU-CHEK in people with Diabetes Mellitus, Type 1, run by Hoffmann-La Roche at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
ACCU-CHEK
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
11 sitesUnited States
Study dates
30 Dec 2015to 20 Feb 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Huntington Beach, California, 92648

  • Study site

    Lincoln, Nebraska, 68521

  • Study site

    Macon, Georgia, 31210

  • Study site

    Montgomery, Alabama, 36105

  • Study site

    Ocean Springs, Mississippi, 39564

  • Study site

    Plano, Texas, 75075

  • Study site

    Pottstown, Pennsylvania, 19464

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

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

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.

Being tested
ACCU-CHEK
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02600845
Study groupRoleWhat they receive
ACCU-CHEKExperimentalAll 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.
Receives: Device: ACCU-CHEK

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (11)

  1. 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.

    Measured: Baseline, Week 24

  2. 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.

    Measured: Baseline, Weeks 12 and 24

  3. 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).

    Measured: Baseline, Week 24

  4. 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.

    Measured: Baseline, Week 24

  5. 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.

    Measured: Baseline, Week 24

  6. 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.

    Measured: Baseline, Weeks 12 and 24

  7. 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.

    Measured: Week 24

  8. 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.

    Measured: Up to Week 24

  9. 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.

    Measured: Baseline, Weeks 12 and 24

  10. 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.

    Measured: Baseline, Weeks 12 and 24

  11. 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.

    Measured: Weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2015 (estimated)
  2. Study start30 Dec 2015
  3. Primary completion29 Sep 2016
  4. Study completion20 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02600845
Sponsor's protocol ID
RD002206
Status last verified
Oct 2017
First submitted
6 Nov 2015
Last updated
6 Nov 2017
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 29027812

Questions about this trial

What is this clinical trial studying?

A study testing ACCU-CHEK in people with Diabetes Mellitus, Type 1, run by Hoffmann-La Roche at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02600845, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in