Freestyle Libre and Hospital Admissions in Type 2 Diabetes (STRATUS)

University of Leeds

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification; Device: Freestyle libre

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04997512

STRATUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Participants are returned to the care of their usual diabetes care provider following randomisation. They will donate blood and urine samples as well as completing diabetes specific questionnaires at 0 and 6 months. They will also wear a blinded glucose sensor (freestyle Libre PRO) for a two week period at month 6.

Intervention arm

Experimental group

Description:

Participants will be randomised at baseline. They will provide blood and urine samples at months 0 and 6 as well as fill in diabetes specific questionnaires. They will receive education surrounding hypoglycaemia at baseline from a diabetes specialist nurse. They will wear a freestyle libre device which is changed every two weeks for a period of 6 months. At weeks 2,4,12 and 24 they will have their diabetes medication adjusted by the diabetes specialist nurse/diabetes doctor according to their blood glucose profiles, analysed from the data generated by freestyle libre.

Treatment:

Other: Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification

Device: Freestyle libre