Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02105103
First received: March 28, 2014
Last updated: August 26, 2014
Last verified: October 2013
  Purpose

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, pr ospective, 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 beenn on intensive insulin therapy for at least siz months i.e. either on CSII or MDI.All Subjects will receive traini ng in the preparation, programming and daily use of the Accu-Chek Insight Insuli n pump.In addition, subjects previously on MDI may receive more training in orde r 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 subj ects will be enrolled in this study.


Condition Intervention
Type 2 Diabetes, Type 1 Diabetes
Device: Accu-Chek® Insight Insulin Pump

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Evaluate subject satisfaction based on surveys of important factors of health-related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate change in HbA1c from screening to month 3 and 6 [ Time Frame: 3 weeks screening plus 6 months treatment period ] [ Designated as safety issue: No ]
  • Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate change in CGM-derived parameters from month 3 to month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105103

Contacts
Contact: Rudolf Prager +43-180-110 rudolf.prager@wienkav.at

Locations
Austria
Recruiting
Graz, Austria, 8036
Recruiting
Vienna, Austria, 1130
France
Recruiting
Avignon, France, 84902
Recruiting
Nevers, France, 8P 649
Recruiting
Strasbourg Cedex, France, 67091
United Kingdom
Recruiting
Birmingham, United Kingdom, B9 SSS
Recruiting
Birmingham, United Kingdom, B15 2WB
Recruiting
Blackburn, United Kingdom, BB23HH
Recruiting
Leicester, United Kingdom, LE15WW
Recruiting
Middlesborough, United Kingdom, TS4 3BW
Recruiting
Stafford, United Kingdom, ST16 2ST
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Linda Amstutz Roche Diagnostics GmbH
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02105103     History of Changes
Other Study ID Numbers: RD001514
Study First Received: March 28, 2014
Last Updated: August 26, 2014
Health Authority: Austria: Institut Inspektionen, Medizinprodukte & Hamovigilanz

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014