Type 2 DiabetesSTRATUSNCT04997512
Freestyle Libre and Hospital Admissions in Type 2 Diabetes
A study testing Freestyle libre and Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification in people with Type 2 Diabetes, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Freestyle libre and Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >18
- Confirmed diagnosis of type 2 diabetes
- Suffered an episode of severe hypoglycaemia requiring ambulance call out
- Able to provide informed written consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes centre, St James hospital
Leeds, West Yorkshire, LS97TF
About this study
Official title: 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.
Read the 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
- Being tested
- Freestyle libre, Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification
- Keywords
- Hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle libreDevice
A glucose sensor (flash) which measures interstitial blood glucose every 15 minutes or on demand.
Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | 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 | 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. Receives: Device: Freestyle libre; Other: Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 2 years
Rates of death between groups at 2 years
Measured: 2 years
Secondary outcomes (10)
All-cause mortality at 1 year
Mortality at 12 months from randomisation
Measured: 12 months
Cardiovascular mortality at 1 year
Mortality from a cardiovascular cause at 1 year
Measured: 1 year
Cardiovascular mortality at 2 years
Mortality from a cardiovascular cause at 2 years
Measured: 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
Measured: 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
Measured: 6 months
Change from baseline in HbA1c
Change from baseline HbA1c at 6 months between both groups
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Tested at 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial (not blinded due to study design)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care
- Responsible party
- Principal investigator, Ramzi Ajjan, University of Leeds
- Investigators
- Ramzi A Ajjan, PHD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997512
- Sponsor's protocol ID
- STRATUS
- Acronym
- STRATUS
- Status last verified
- Sep 2021
- First submitted
- 26 Jul 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data will be available on reasonable request to the investigators
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeSTyle LibRe and hospitAl Admissions, morTality and qUality of Life in High Risk Type 2 diabeteS Patients
- ClinicalTrials.gov ID
- NCT04997512
- Acronym / sponsor ID
- STRATUS / STRATUS
- Conditions
- Type 2 Diabetes
- Keywords
- Hypoglycaemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial (not blinded due to study design)
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –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 | Device: Freestyle libre, Other: Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modificationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >18
- Confirmed diagnosis of type 2 diabetes
- Suffered an episode of severe hypoglycaemia requiring ambulance call out
- Able to provide informed written consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freestyle libreA glucose sensor (flash) which measures interstitial blood glucose every 15 minutes or on demand. | Device | Intervention arm |
| Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modificationAn 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. | Other | Intervention arm |
Primary outcome
Mortality at 2 years
Time frame: 2 years
Rates of death between groups at 2 years
10 secondary outcomes
All-cause mortality at 1 year
Time frame: 12 months
Cardiovascular mortality at 1 year
Time frame: 1 year
Cardiovascular mortality at 2 years
Time frame: 2 years
Number of unscheduled healthcare contacts
Time frame: 2 years after randomisation
Comparison between estimated HbA1c and laboratory HbA1c
Time frame: 6 months
Change from baseline in HbA1c
Time frame: 6 months
Scores from Diabetes distress scale
Time frame: Tested at 0 and 6 months
Scores from diabetes quality of life scale (DQOL)
Time frame: Tested at 0 and 6 months
Scores from treatment satisfaction scale (DTSQc)
Time frame: Tested at 0 and 6 months
Scores from GOLD score
Time frame: Tested at 0 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No. Anonymised data will be available on reasonable request to the investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramzi A Ajjan, PHD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freestyle libre and Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification in people with Type 2 Diabetes, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramzi A Ajjan, PHD (07796676643, R.ajjan@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.