Glucose Level Awareness (using self-monitoring of blood glucose [SMBG] and continuous glucose monitoring [CGM]) in Diabetes Study

ISRCTN	ISRCTN39531284
DOI	https://doi.org/10.1186/ISRCTN39531284
Secondary identifying numbers	ADC-PMR-NAV-10009

Submission date: 18/01/2011
Registration date: 18/02/2011
Last edited: 18/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John New
Scientific

Salford Royal NHS Foundation Trust, Stott Lane
Salford
M6 8HD
United Kingdom

Study information

Study design	Multicentre randomised controlled three-arm study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	GLADIS
Study objectives	To demonstrate clinical benefit of continuous glucose monitoring (CGM) relative to self-monitoring of blood glucose (SMBG).
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	31/01/2011
Completion date	01/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150
Key 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
Key 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
Date of first enrolment	31/01/2011
Date of final enrolment	01/05/2012

Locations

Countries of recruitment

England
Germany
United Kingdom

Study participating centre

Salford Royal NHS Foundation Trust

Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor information

Abbott Diabetes Care Ltd (UK)
Industry

c/o Liz Phipps
Range Road
Witney
OX29 0YL
United Kingdom

Website	http://www.abbottdiabetescare.co.uk/
"ROR"	https://ror.org/03wnay029

Funders

Funder type

Industry

Abbott Diabetes Care Ltd

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2015		Yes	No

Editorial Notes

18/07/2016: Publication reference added.
13/03/2012: The anticipated end date has been modified from 01/09/2011 to 01/05/2012.