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.

Not Applicable

Completed

• Conditions: Type 2 Diabetes, Type 1 Diabetes
• Interventions: Device: Accu-Chek® Insight Insulin Pump

• Registration Number: NCT02105103
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accu-Chek® Insight Insulin Pump	Accu-Chek® Insight Insulin Pump	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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