Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
SIGN
1 other identifier
interventional
105
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus
Started Oct 2012
Shorter than P25 for phase_4 diabetes-mellitus
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
March 11, 2015
CompletedMarch 4, 2016
February 1, 2016
7 months
October 22, 2012
February 26, 2015
February 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Time in Range
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
Study Arms (2)
CGM - intervention arm
EXPERIMENTALFollowing 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
ACTIVE COMPARATORFollowing 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.
Interventions
Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Ayr Hospital
Ayr, Ayrshire, KA6 6DX, United Kingdom
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, OL6 9RW, United Kingdom
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Birmingham Heartlands Hospital, Diabetes Clinic
City and Borough of Birmingham, B9 5SS, United Kingdom
University Hospital of North Durham
Durham, DH1 5TW, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, IP4 5PD, United Kingdom
St James Hospital,
Leeds, LS9 7TF, United Kingdom
Rotherham General Hospital
Rotherham, S60 2UD, United Kingdom
Diabetes Centre, New Cross Hospital,
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Snr Director, Clinical Development & Regulatory Affairs
- Organization
- Abbott Diabetes Care
Study Officials
- PRINCIPAL INVESTIGATOR
Ramzi Ajjan
St James Hospital, Leeds
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 24, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
March 4, 2016
Results First Posted
March 11, 2015
Record last verified: 2016-02