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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.

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ClinicalTrials.gov Identifier: NCT02105103
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes, Type 1 Diabetes Device: Accu-Chek® Insight Insulin Pump Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.)



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Evaluate subject satisfaction based on surveys of important factors of health-related quality of life [ Time Frame: 6 months ]
  3. Evaluate change in HbA1c from screening to month 3 and 6 [ Time Frame: 3 weeks screening plus 6 months treatment period ]
  4. Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types) [ Time Frame: 6 months ]
  5. Evaluate change in CGM-derived parameters from month 3 to month 6 [ Time Frame: 6 months ]
  6. Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105103


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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Bettina Petersen Roche Diagnostics

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02105103     History of Changes
Other Study ID Numbers: RD001514
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016

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