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.

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Type 2 Diabetes, Type 1 Diabetes
Interventions
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.)

Trial Locations (8)

1130

Vienna

8036

Graz

B15 2WB

Birmingham

B9 SSS

Birmingham

BB23HH

Blackburn

LE15WW

Leicester

TS4 3BW

Middlesbrough

ST16 2ST

Stafford

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02105103 - 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. | Biotech Hunter | Biotech Hunter