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.

Type 2 Diabetes, Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105103
• Other study ID #: RD001514
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: September 8, 2016
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Institut Inspektionen, Medizinprodukte & Hamovigilanz
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 2 Diabetes, Type 1 Diabetes

Intervention

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.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 months	No
Secondary	Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures		6 months	Yes
Secondary	Evaluate subject satisfaction based on surveys of important factors of health-related quality of life		6 months	No
Secondary	Evaluate change in HbA1c from screening to month 3 and 6		3 weeks screening plus 6 months treatment period	No
Secondary	Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)		6 months	No
Secondary	Evaluate change in CGM-derived parameters from month 3 to month 6		6 months	No
Secondary	Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages		6 months	No