NCT04997512

Freestyle Libre and Hospital Admissions in Type 2 Diabetes

FreeSTyle LibRe and hospitAl Admissions, morTality and qUality of Life in High Risk Type 2 diabeteS Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Freestyle libre	A glucose sensor (flash) which measures interstitial blood glucose every 15 minutes or on demand.
OTHER	Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification	An education programme surrounding avoidance of hypoglycaemia at baseline. Regular review (weeks 2, 4, 12 and 24) and adjustment of diabetes medications based on freestyle libre data.

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2021-08-09
• Last updated: 2021-09-08

Locations

1 site across 1 country: United Kingdom