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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: FreeStyle InsuLinx; Device: FreeStyle Freedom Lite

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Mergentheim, Germany, 97980
    • Diabetes Zentrum Mergentheim
  • Hannover, Germany, 30173
    • Diabetes-Zentrum für Kinder und Jugendliche
  • Ulm, Germany, D-89081
    • Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm
• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • VU University Medical Centre (VUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Subjects will use a FreeStyle InsuLinx blood glucose meter during the study	Device: FreeStyle InsuLinx; FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
Other: Control; Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.	Device: FreeStyle Freedom Lite; FreeStyle Freedom Lite is a blood glucose meter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Target Blood Glucose Range	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. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)	Day 1-15 compared with Day 60-74

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).	Day 1 compared with Day 74
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.	The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied). The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.	Day 60 compared to day 1

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Principal Investigator: Prof. Michaela Diamant, VU University Medical Centre (VUMC)

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes; SMBG; Insulin calculator
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: ADC-PMR-INX-11012