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Can we prevent recurrent severe low blood glucose reactions using a new glucose sensing device?

Assessment of the utility of the Flash Libre subcutaneous glucose monitoring system to prevent recurrent severe hypoglycaemia in patients with diabetes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001695493
Enrollment
59
Registered
2016-12-09
Start date
2017-09-01
Completion date
2018-07-02
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will determine whether a new relatively non-invasive glucose monitoring system (Flash Libre) helps adults with diabetes who have a severe glucose reaction to avoid further such episodes. The hypothesis is that the non-invasive system will be superior to usual care in preventing both severe and non-severe hypoglycaemia after the index severe hypoglcyaemic event.

Interventions

Patients with a documented episode of severe hypoglycaemia will be randomised to the Flash Libre subcutaneous glucose sensing system or usual care over a 6-month follow-up period. The Flash Libre device is an adhesive sensor disc with a thin needle that is placed on the upper arm and which can be read as required. Each sensor lasts 2 weeks before it has to be replaced (patients allocated to this arm will be using the device continuously for 6 months) and is precalibrated so that the patient does

Patients with a documented episode of severe hypoglycaemia will be randomised to the Flash Libre subcutaneous glucose sensing system or usual care over a 6-month follow-up period. The Flash Libre device is an adhesive sensor disc with a thin needle that is placed on the upper arm and which can be read as required. Each sensor lasts 2 weeks before it has to be replaced (patients allocated to this arm will be using the device continuously for 6 months) and is precalibrated so that the patient does not need to do any finger prick blood glucose readings. The readings can be downloaded to a PC which will also be access by the Study Nurse to assess compliance. Training on use of the Flash Libre system will be implemented by the Study Nurse but the patients themselves will insert each sensor, and perform data collection at least 4 times per day and when a hypoglycaemic episode is suspected. The Research Nurse will also co-ordinate usual care for those randomised to this arm. Both intervention (Flash Libre) and usual care patients will have a 30-minute face-to-face session with the Research Nurse as soon as possible after the index severe hypoglycaemic episode. The Nurse will perform a review of medication and self blood glucose monitoring, re-educate patients as to avoidance measures and ensure that the patient's usual health care professionals are aware of the hypoglycaemic episode so that they can take over care in the community.

Sponsors

University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Adults with diabetes who experiencean episode of severe hypoglycaemia as an inpatient or who attend the Emergency Department with severe hypoglycaemia

Exclusion criteria

Not able to operate the Flash Libre device due to cognitive or visual impairment. Allergy to the adhesive used to attach the sensor in place,

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026