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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Freestyle libre; Other: Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramzi A Ajjan, PHD; Phone Number: 07796676643; Email: R.ajjan@leeds.ac.uk

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS97TF
      • Diabetes centre, St James hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; 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.
Experimental: Intervention arm; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 2 years	Rates of death between groups at 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 1 year	Mortality at 12 months from randomisation	12 months
Cardiovascular mortality at 1 year	Mortality from a cardiovascular cause at 1 year	1 year
Cardiovascular mortality at 2 years	Mortality from a cardiovascular cause at 2 years	2 years
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
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
Change from baseline in HbA1c	Change from baseline HbA1c at 6 months between both groups	6 months
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Abbott Diabetes Care
• Investigators: Principal Investigator: Ramzi A Ajjan, PHD, University of Leeds

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hypoglycaemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STRATUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Anonymised data will be available on reasonable request to the investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No