Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/01/2011
Date assigned
18/02/2011
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John New

ORCID ID

Contact details

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

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 investigatorÂ’s 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

http://www.abbottdiabetescare.co.uk/

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

Publication citations

Additional files

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.