Status:
COMPLETED
Hypo-METRICS: Hypoglycaemia - Measurement, ThResholds and ImpaCtS
Lead Sponsor:
King's College London
Collaborating Sponsors:
University of Southern Denmark
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-85 years
Brief Summary
Hypoglycaemia or low blood glucose, and its fear are major barriers to achieving optimal glucose control. New technology, such as continuous glucose monitors (CGM), help to better identify hypoglycaem...
Eligibility Criteria
Inclusion
- Age 18 - 85 years
- HbA1c 5 - 10% \[31 - 86 mmol/mol\]
- Confirmed diagnosis of type 1 or type 2 diabetes
- Using \> 1 injection of insulin / day or insulin pump.
- Ability to provide written informed consent
- Performing regular SMBG \[ \> 1 / day on a 4-week download\] . For those using flash or continuous glucose monitoring, this should be used at least 70% of the time.
- At least 1 episode of hypoglycaemia \[ either biochemical or symptomatic\] in the last month
- On stable therapy for at least 3 months.
- Willing to complete study procedures including wearing the Fitbit and CGM devices and completing the EMA questionnaires on the uMotif app three times a day for 10 weeks ( we expect minimum 80% data completeness)
Exclusion
- Concurrent conditions that can affect glucose readings \[renal impairment GFR \< 30 ml/min, hepatic impairment, untreated adrenal or thyroid insufficiency, as judged by the investigator.
- Severe cognitive impairment or psychological illness that can impair performance of EMA tasks, visual impairment that will preclude use of the EMA or sensors.
- Severe psychiatric / psychological illness including extreme fear of hypo- or hyper- glycaemia ( in the opinion of the investigator)
- Pregnant or plans for pregnancy in the next 6 months
- Use of automated insulin delivery systems such as closed loop or automated threshold suspend or predictive low glucose suspend insulin pumps.
- Known allergies to adhesives required for the CGM systems
- People who work regular night shifts
- Any other condition which in the opinion of the study team would impair their ability to complete the study
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT04304963
Start Date
October 1 2020
End Date
October 31 2022
Last Update
October 11 2023
Active Locations (1)
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1
King's College London
London, United Kingdom