Clinical trial NCT01713348: Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
Official title: Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: CGM
MDI
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2012-10-24
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time in Range
timeFrame: Day 86 to 100 compared to Day 1 to 15
Secondary outcomes:
measure: Time in Range
timeFrame: Days 86 to 100 intervention arm compared to control arm
measure: Glucose Standard Deviation (SD)
timeFrame: Day 86 to 100 compared to day 1 to 15
measure: HbA1c (mmol/Mol)
timeFrame: Day 100 compared to day 1
measure: HbA1c
timeFrame: Day 100 compared to day 1
Other outcomes:
Locations:
city: Ayr
country: United Kingdom
facility: Ayr Hospital
state: Ayrshire
city: Ashton-under-Lyne
country: United Kingdom
facility: Tameside Hospital NHS Foundation Trust
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: City and Borough of Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital, Diabetes Clinic
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital NHS Trust
city: Leeds
country: United Kingdom
facility: St James Hospital,
city: Rotherham
country: United Kingdom
facility: Rotherham General Hospital
city: Wolverhampton,
country: United Kingdom
facility: Diabetes Centre, New Cross Hospital,
Study officials:
affiliation: St James Hospital, Leeds
name: Ramzi Ajjan
role: PRINCIPAL_INVESTIGATOR
References: