Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes

Study Overview
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Brief Summary
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To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by; regularly checking and understanding Continuous Glucose data & trend arrows at times other than the standard pre-meal bolus calculation test times and review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care Professional (HCP) and adjusting behaviours & therapy from interpretation of the Continuous Glucose profiles.

Official Title
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Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: FreeStyle Navigator
* Device: Standard SMBG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and over Type 1 diabetes on MDI with bolus injections for >6 months prior to study enrolment or Type 2 diabetes treated with 2 or more insulin injections daily. In the investigator's opinion, thought technically capable of using FreeStyle Navigator GM System device. HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6 months prior to point of enrolment Exclusion Criteria: Concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any uncontrolled chronic medical condition Female subject is pregnant or planning to become pregnant within the planned study duration. Subjects who become pregnant during the study will be discontinued from the study. Currently using / has previously used a Continuous Glucose Monitoring System within the last 6 months. Currently using Continuous Subcutaneous Insulin Infusion (CSII) Currently using basal/long acting insulin only. Participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management Known allergy to medical grade adhesives In the investigators opinion is unsuitable to participate due to any other cause/reason.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM - intervention arm<br>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. | Device: FreeStyle Navigator<br>* Masked CGM day 1 to 15, unmasked CGM days 15 to 100<br>|
| Active Comparator: SMBG - Control arm<br>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. | Device: Standard SMBG<br>* Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range | Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes. | Day 86 to 100 compared to Day 1 to 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range | Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm. | Days 86 to 100 intervention arm compared to control arm | 
| Glucose Standard Deviation (SD) |  | Day 86 to 100 compared to day 1 to 15 | 
| HbA1c (mmol/Mol) |  | Day 100 compared to day 1 | 
| HbA1c |  | Day 100 compared to day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM, MDI