European, Open-label, Prospective, Multinational, Multicenter Study in Adult Subjects With Type 1 or Type 2 Diabetes Previously on MDI or CSII Therapy. Subjects Home Setting is Considered Routine Practice.

September 8, 2016 updated by: Hoffmann-La Roche

Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice

Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects will receive training in the preparation, programming and daily use of the Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more training in order to be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
      • Vienna, Austria, 1130
  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
      • Birmingham, United Kingdom, B9 SSS
      • Blackburn, United Kingdom, BB23HH
      • Leicester, United Kingdom, LE15WW
      • Middlesborough, United Kingdom, TS4 3BW
      • Stafford, United Kingdom, ST16 2ST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female at least 18 years old
  • Diagnosed at least for 12 months with Type 1 or 2 Diabetes requiring insulin therapy
  • Intensive insulin therapy by MDI or CSII at least 6 months
  • Willing to self monitor blood glucose 4 times daily

Exclusion Criteria:

  • Significantly impaired awareness of hypoglycemia
  • Unstable chronic disease other than diabetes
  • Acute illness or inability to recognize pump signals or alarms as determined by the investigator
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Accu-Chek® Insight Insulin Pump
Device: Accu-Chek® Insight Insulin Pump
A new insulin pump, the Accu-Chek® Insight insulin pump, will be used by all subjects enrolled in this study. The usability of the Accu-Chek® Insight insulin pump for the intended use has already been investigated in a Human Factor study. The study subjects may encounter the following potential risks of CSII therapy while participating in the study: Possible hypoglycemia; Possible hyperglycemia which might progress to ketosis and DKA; Infusion site reactions (bleeding, bruising, discomfort, pruritus, pain, plaster reactions, inflammation, infection etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures
Time Frame: 6 months
6 months
Evaluate subject satisfaction based on surveys of important factors of health-related quality of life
Time Frame: 6 months
6 months
Evaluate change in HbA1c from screening to month 3 and 6
Time Frame: 3 weeks screening plus 6 months treatment period
3 weeks screening plus 6 months treatment period
Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
Time Frame: 6 months
6 months
Evaluate change in CGM-derived parameters from month 3 to month 6
Time Frame: 6 months
6 months
Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Bettina Petersen, Roche Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD001514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes, Type 1 Diabetes

Clinical Trials on Accu-Chek® Insight Insulin Pump

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe