Clinical trial NCT04997512: Freestyle Libre and Hospital Admissions in Type 2 Diabetes
Official title: FreeSTyle LibRe and hospitAl Admissions, morTality and qUality of Life in High Risk Type 2 diabeteS Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Hypoglycaemia
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
First posted: 2021-08-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial (not blinded due to study design)
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the utility of a combination of structured nurse led intervention and the use of Freestyle libre in adults with type 2 diabetes who have suffered an episode of severe hypoglycaemia in terms of mortality, unscheduled healthcare contacts and quality of life.

Detailed description: It is increasingly recognised that hypoglycaemia carries risk to individuals with all forms of diabetes. Research has shown high rate of mortality in those with type 2 diabetes following an episode of severe hypoglycaemia and a previous pilot trial conducted in the UK suggested that this could be improved by a structured nurse led intervention aimed at modifying glycemic therapy to avoid hypoglycaemia, instigating regular blood glucose monitoring and providing education to participants on common triggers for hypoglycaemia and how to avoid them.

In this trial, the investigators will randomise individuals with type 2 diabetes who have suffered an episode of severe hypoglycaemia requiring emergency service call out to two arms. One arm will receive standard of care/treatment as usual and the other will receive a structured nurse led intervention as well as the use of a flash glucose monitoring system, Freestyle libre.

Active participation in the trial for both arms will be a total of twelve months (with the main intervention months 0-6.) Participants electronic records will be analysed for death and unscheduled healthcare contacts for a total of two years after recruitment.

The primary outcome measure is mortality between groups. Secondary outcomes include the use of estimated HbA1c (a variable produced by the freestyle libre device) compared to laboratory HbA1c, quality of life measures, effects on glycemic control and the number of unscheduled healthcare contacts.

Eligibility criteria: Inclusion criteria

* Aged \>18
* Confirmed diagnosis of type 2 diabetes
* Suffered an episode of severe hypoglycaemia requiring ambulance call out
* Able to provide informed written consent

Exclusion criteria

* A form of diabetes mellitus which is not type 2 or the diagnosis is uncertain
* Currently pregnant
* Dialysis dependent renal failure
* Unable to provide informed written consent

Primary outcomes:
measure: Mortality at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: All-cause mortality at 1 year
timeFrame: 12 months
measure: Cardiovascular mortality at 1 year
timeFrame: 1 year
measure: Cardiovascular mortality at 2 years
timeFrame: 2 years
measure: Number of unscheduled healthcare contacts
timeFrame: 2 years after randomisation
measure: Comparison between estimated HbA1c and laboratory HbA1c
timeFrame: 6 months
measure: Change from baseline in HbA1c
timeFrame: 6 months
measure: Scores from Diabetes distress scale
timeFrame: Tested at 0 and 6 months
measure: Scores from diabetes quality of life scale (DQOL)
timeFrame: Tested at 0 and 6 months
measure: Scores from treatment satisfaction scale (DTSQc)
timeFrame: Tested at 0 and 6 months
measure: Scores from GOLD score
timeFrame: Tested at 0 and 6 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Diabetes centre, St James hospital
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Ramzi A Ajjan, PHD
role: PRINCIPAL_INVESTIGATOR
References: