Status:
COMPLETED
Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.
Eligibility Criteria
Inclusion
- Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
- HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
- Age 18 and over
- In the investigator's opinion, thought technically capable of using masked CGM
- Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
- Willing to perform a minimum of 4 SMBG tests per day during study
Exclusion
- Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
- Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
- Subject is pregnant / planning to become pregnant within the planned study timeline
- Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
- Subject is currently on an insulin pump
- Subject is currently using the FreeStyle InsuLinx
- Subject is currently using the FreeStyle Freedom Lite
- Subject is currently using CGM
- Subject has an allergy to medical grade adhesives
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01519466
Start Date
January 1 2012
End Date
October 1 2012
Last Update
April 1 2016
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabetes Zentrum Mergentheim
Bad Mergentheim, Germany, 97980
2
Diabetes-Zentrum für Kinder und Jugendliche
Hanover, Germany, 30173
3
Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany, D-89081
4
VU University Medical Centre (VUMC)
Amsterdam, Netherlands, 1007 MB