Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Sev… (NCT03748433) | Clinical Trial Compass
TerminatedNot Applicable
Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia
Stopped: Terminated early after the interim analysis. It was deemed unethical to offer self-monitored blood glucose to this high risk population
United Kingdom35 participantsStarted 2019-01-03
Plain-language summary
This study aims to assess the impact of real-time continuous glucose monitoring on the frequency, duration, awareness and severity of hypoglycaemia in people with type 1 diabetes and a recent history of severe hypoglycaemia, compared to usual care.
Who can participate
Age range18 Years
SexALL
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PRE-REGISTRATION EVALUATIONS
* Episode of severe hypoglycaemia
* Age \>18 years
* Diagnosis of type 1 diabetes
INCLUSION CRITERIA
* Adults over 18 years of age
* Severe hypoglycaemia requiring ambulance call-out or emergency department attendance within 2 weeks
* Type 1 diabetes confirmed on the basis of clinical features
* Type 1 diabetes for greater than 3 years
EXCLUSION CRITERIA
* Use of CGM within the last 6 months (except short periods of diagnostic blinded use under clinic supervision). Prior use of Abbott FreeStyle Libre Device is permitted.
* Use of pre-mixed insulin
* No access to smartphone or computer
* Pregnant or planning pregnancy
* Breastfeeding
* Have active malignancy or under investigation for malignancy
* Severe visual impairment
* Reduced manual dexterity
* Unable to participate due to other factors, as assessed by the Chief Investigators
WITHDRAWAL CRITERIA
Participants will be withdrawn if their ability to give informed consent is impaired. Participants will also be withdrawn, at the chief investigators discretion, if glucose control is negatively impacted by the use of either intervention.