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.
Primary Purpose
Type 2 Diabetes, Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Accu-Chek® Insight Insulin Pump
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes, Type 1 Diabetes
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Accu-Chek® Insight Insulin Pump
Arm Description
Outcomes
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).
Secondary Outcome Measures
Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures
Evaluate subject satisfaction based on surveys of important factors of health-related quality of life
Evaluate change in HbA1c from screening to month 3 and 6
Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
Evaluate change in CGM-derived parameters from month 3 to month 6
Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02105103
Brief Title
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.
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Type 1 Diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accu-Chek® Insight Insulin Pump
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Accu-Chek® Insight Insulin Pump
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
Evaluate subject satisfaction based on surveys of important factors of health-related quality of life
Time Frame
6 months
Title
Evaluate change in HbA1c from screening to month 3 and 6
Time Frame
3 weeks screening plus 6 months treatment period
Title
Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
Time Frame
6 months
Title
Evaluate change in CGM-derived parameters from month 3 to month 6
Time Frame
6 months
Title
Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Petersen
Organizational Affiliation
Roche Diagnostics
Official's Role
Study Director
Facility Information:
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Vienna
ZIP/Postal Code
1130
Country
Austria
City
Birmingham
ZIP/Postal Code
B15 2WB
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B9 SSS
Country
United Kingdom
City
Blackburn
ZIP/Postal Code
BB23HH
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE15WW
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Stafford
ZIP/Postal Code
ST16 2ST
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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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