Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ADC-PMR-NAV-10009
Study information
Scientific title
Glucose Level Awareness (using self-monitoring of blood glucose [SMBG] and continuous glucose monitoring [CGM]) in Diabetes Study: a multicentre randomised controlled three-arm study
Acronym
GLADIS
Study hypothesis
To demonstrate clinical benefit of continuous glucose monitoring (CGM) relative to self-monitoring of blood glucose (SMBG).
Ethics approval
1. UK: Sheffield Research Ethics Committee, 21/12/2010, ref: 10/H1308/77
2. Germany: Stuttgart Ethics Committee, 02/12/2010, ref: F-2010-090
Study design
Multicentre randomised controlled three-arm study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes
Intervention
Following a 20 day masked (baseline) period using the Freestyle Navigator subjects will be randomised into one of 3 groups for the next 80 days:
1. The first group will wear the FreeStyle Navigator for the remaining duration of the study
2. The second group will wear the FreeStyle Navigator with glucose alarms switched off
3. The third (control) group will manage their blood glucose with standard SMBG and use a FreeStyle Navigator masked for two, 20-day periods between 40 to 60 days and 80 to 100 days
For all 3 groups, subjects will complete Quality of Life Questionnaires and have HbA1c measurements at both baseline and day 100.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Time spent outside of glucose target: no alarms versus SMBG (days 80 - 100)
Secondary outcome measures
1. Time spent outside of glucose target: no alarms versus CGM (days 80 - 100)
2. Time spent outside of glucose target: CGM versus SMBG (days 80 - 100)
3. Time spent outside of glucose target (days 40 - 60)
4. HbA1c
5. Average glucose (days 40 - 60 and 80 - 100)
6. Glucose variability (days 40 - 60 and 80 - 100)
7. Quality of life measures
8. Adverse events
Overall trial start date
31/01/2011
Overall trial end date
01/05/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Inclusion criteria as of 13/03/2012:
1. Subject with type 1 or type 2 diabetes on multiple daily injections (MDI) (3 or more insulin injections per day) or continuous subcutaneous insulin infusion (CSII) for greater than 6 months prior to study enrolment
2. Aged 18 - 65 years, either sex and, in the Investigator's opinion, thought technically capable of using CGM
3. HbA1c between 7% and 11% (inclusive) for previous HbA1c test obtained within 3 months prior to enrolment
4. Subject reporting testing of blood glucose an average of 2 - 7 times per day
Previous inclusion criteria
1. Subject with type 1 or type 2 diabetes on multiple daily injections (MDI) (3 or more insulin injections per day) or continuous subcutaneous insulin infusion (CSII) for greater than 1 year prior to study enrolment
2. Aged 18 - 65 years, either sex and, in the Investigator's opinion, thought technically capable of using CGM
3. HbA1c between 7.5% and 10% (inclusive) for previous HbA1c test obtained within 3 months prior to enrolment
4. Subject reporting testing of blood glucose an average of 2 - 7 times per day
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Subject has known allergy to medical grade adhesives
2. Subject has concomitant disease or condition that influences metabolic control or, in the investigators opinion, may compromise patient safety
3. Subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
4. Subject is currently using another continuous glucose monitoring device or has used real-time continuous glucose monitoring in the last 6 months
5. Subject is pregnant/planning to become pregnant within the planned study duration
Recruitment start date
31/01/2011
Recruitment end date
01/05/2012
Locations
Countries of recruitment
Germany, United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Abbott Diabetes Care Ltd (UK)
Sponsor details
c/o Liz Phipps
Range Road
Witney
OX29 0YL
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Abbott Diabetes Care Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25661981