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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: FreeStyle InsuLinx
* Device: FreeStyle Freedom Lite


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, SMBG, Insulin calculator