Freestyle Libre and Hospital Admissions in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— STRATUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04997512
• Other study ID #: STRATUS
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2021
• Source: University of Leeds
• Contact: Ramzi A Ajjan, PHD
• Phone: 07796676643
• Email: R.ajjan[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Diabetes centre, St James hospital	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Abbott Diabetes Care

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 2 years	Rates of death between groups at 2 years	2 years
Secondary	All-cause mortality at 1 year	Mortality at 12 months from randomisation	12 months
Secondary	Cardiovascular mortality at 1 year	Mortality from a cardiovascular cause at 1 year	1 year
Secondary	Cardiovascular mortality at 2 years	Mortality from a cardiovascular cause at 2 years	2 years
Secondary	Number of unscheduled healthcare contacts	Number of unscheduled healthcare contacts (emergency services, hospital attendances, primary care attendances) 1 year prior to randomisation and 2 years after	2 years after randomisation
Secondary	Comparison between estimated HbA1c and laboratory HbA1c	A comparison between estimated HbA1c (freestyle libre generated) and laboratory HbA1c values across the whole study cohort at 0 and 6 months	6 months
Secondary	Change from baseline in HbA1c	Change from baseline HbA1c at 6 months between both groups	6 months
Secondary	Scores from Diabetes distress scale	A questionnaire which assessed the emotional burden diabetes has on the participant. 4 different domains are tested across 17 questions. An overall score is calculated (each question is ranked 1-6 by participants) and the total score is divided by 17. The higher the score (1-6) the more diabetes distress the participant is under. Scores are also calculated across each domain. These are 1) emotional burden 2) Physician associated distress 3) regimen associated distress 4) interpersonal distress	Tested at 0 and 6 months
Secondary	Scores from diabetes quality of life scale (DQOL)	This is a questionnaire with 15 questions filled in by participants. Each question is ranked 1-5 with a score of 5 conveying the worst score. Scores therefore range from 15 to 75 with a score of 75 indicating very poor quality of life as a result of diabetes and 15 very good.	Tested at 0 and 6 months
Secondary	Scores from treatment satisfaction scale (DTSQc)	This is a questionnaire assessing participant satisfaction with the treatment of their diabetes. It comprises 8 questions with each scored from 3 to negative 3. A score of 3 on a question indicates very good satisfaction whereas negative 3 that the participant is most dissatisfied. Therefore a maximum score of 24 is possible with a low score of negative 24. The higher the score, the more satisfied the participant is with their diabetes treatment.	Tested at 0 and 6 months
Secondary	Scores from GOLD score	A 1-7 scale which asks participants how likely they are to recognise hypoglycaemia. 7 indicates they have severe hypoglycaemia awareness and 1 that they are fully hypoglycaemic aware. Therefore the higher the score, the more hypoglycaemic unawareness the participant perceives themself as having.	Tested at 0 and 6 months