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

Not Applicable

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Intervention	FreeStyle InsuLinx	Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
Control	FreeStyle Freedom Lite	Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.

Primary Outcome Measures

Name	Time	Method
Time in Target Blood Glucose Range	Day 1-15 compared with Day 60-74	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)

Secondary Outcome Measures

Name	Time	Method
HbA1c	Day 1 compared with Day 74	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).
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.	Day 60 compared to day 1	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.

Locations (4): 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, Germany
VU University Medical Centre (VUMC)
🇳🇱
Amsterdam, Netherlands