Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

Type 1 Diabetes Clinical Trial

Official title:

Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519466
• Other study ID #: ADC-PMR-INX-11012
• Status: Completed
• Phase: N/A
• First received: January 6, 2012
• Last updated: November 2, 2012
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• FreeStyle InsuLinx
FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
• FreeStyle Freedom Lite
FreeStyle Freedom Lite is a blood glucose meter

Locations

Country	Name	City	State
Germany	Diabetes Zentrum Mergentheim	Bad Mergentheim
Germany	Diabetes-Zentrum für Kinder und Jugendliche	Hannover
Germany	Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm	Ulm
Netherlands	VU University Medical Centre (VUMC)	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in time spent in euglycaemia	Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group.	Day 1-15 compared with Day 60-74	No
Secondary	Change in time spent in euglycaemia	Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will compare the control and intervention groups using analysis of covariance to allow for differences at baseline.	Day 1-15 compared with Day 60-74	No
Secondary	Change in HbA1c	HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). Analysis will assess the difference between the assessment and baseline results for the intervention group and compare the control and intervention groups.	Day 1 compared with Day 74	No
Secondary	Change in Total Daily Dose (TDD) of insulin	5-Day diary data collected during the first 2 weeks of the study will be compared to data collected during the last 2 weeks of the study. Analysis will assess the difference between the assessment and baseline TDD for the intervention group and compare the control and intervention groups.	5-day diary data collected between Days 1-6 compared with 5-day diary data collected between Days 60-74.	No
Secondary	Change in Patient Reported Outcome Measures	Diabetes Treatment Satisfaction Questionnaire (DTSQ), Hypoglycaemia Fear Survey (HFS)and Diabetes Distress Scale(DDS)Questionnaires will be completed at Baseline (Day 1) and visit 6 (approximately day 60)and the scores compared. Analysis will assess the difference between the assessment and baseline scores for the intervention group and compare the control and intervention groups.	Day 1 compared to Day 60	No