NCT04997512

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

July 26, 2021

Last Update Submit

September 7, 2021

Conditions

Type 2 Diabetes

Keywords

Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

  • Mortality at 2 years

    Rates of death between groups at 2 years

    2 years

Secondary Outcomes (10)

  • All-cause mortality at 1 year

    12 months

  • Cardiovascular mortality at 1 year

    1 year

  • Cardiovascular mortality at 2 years

    2 years

  • Number of unscheduled healthcare contacts

    2 years after randomisation

  • Comparison between estimated HbA1c and laboratory HbA1c

    6 months

  • +5 more secondary outcomes

Study Arms (2)

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.

Device: Freestyle libreOther: Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification

Interventions

Freestyle libreDEVICE

A glucose sensor (flash) which measures interstitial blood glucose every 15 minutes or on demand.

Intervention arm
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.

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged \>18
  • Confirmed diagnosis of type 2 diabetes
  • Suffered an episode of severe hypoglycaemia requiring ambulance call out
  • Able to provide informed written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes centre, St James hospital

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ramzi A Ajjan, PHD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramzi A Ajjan, PHD

CONTACT

07796676643R.ajjan@leeds.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Unable to mask participants and trailists due to study design.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial (not blinded due to study design)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of metabolic medicine

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 9, 2021

Study Start

November 1, 2021

Primary Completion

August 1, 2024

Study Completion

August 1, 2025

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Anonymised data will be available on reasonable request to the investigators

Locations

GB(1)