Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
- Conditions
- Diabetes Mellitus
- Interventions
- Device: FreeStyle NavigatorDevice: Standard SMBG
- Registration Number
- NCT01713348
- Lead Sponsor
- Abbott Diabetes Care
- Brief Summary
To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by;
1. regularly checking and understanding Continuous Glucose data \& trend arrows at times other than the standard pre-meal bolus calculation test times and
2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CGM - intervention arm FreeStyle Navigator Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. SMBG - Control arm Standard SMBG 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.
- Primary Outcome Measures
Name Time Method Time in Range Day 86 to 100 compared to Day 1 to 15 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.
- Secondary Outcome Measures
Name Time Method Glucose Standard Deviation (SD) Day 86 to 100 compared to day 1 to 15 HbA1c (mmol/Mol) Day 100 compared to day 1 Time in Range Days 86 to 100 intervention arm compared to control arm Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.
HbA1c Day 100 compared to day 1
Trial Locations
- Locations (9)
Tameside Hospital NHS Foundation Trust
🇬🇧Ashton-under-Lyne, United Kingdom
University Hospital of North Durham
🇬🇧Durham, United Kingdom
Rotherham General Hospital
🇬🇧Rotherham, United Kingdom
Diabetes Centre, New Cross Hospital,
🇬🇧Wolverhampton,, United Kingdom
Royal United Hospital
🇬🇧Bath, United Kingdom
Birmingham Heartlands Hospital, Diabetes Clinic
🇬🇧City and Borough of Birmingham, United Kingdom
Ayr Hospital
🇬🇧Ayr, Ayrshire, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, United Kingdom
St James Hospital,
🇬🇧Leeds, United Kingdom