Status:
COMPLETED
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
DexCom, Inc.
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
16-297 years
Phase:
NA
Brief Summary
The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adul...
Detailed Description
This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor dai...
Eligibility Criteria
Inclusion
- Age between 16 - 24 years old (inclusive)
- Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment
- Treated with insulin pump or MDI
- Has a Smart phone compatible with Dexcom G5 or similar
- Willingness to wear study devices
- Willing to follow study specific instructions
- Literate in English
Exclusion
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study
- Untreated celiac disease or hypothyroidism
- Current or planned users of real-time or flash (Libre) glucose monitoring sensors
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers and MAO inhibitors etc.
- Regular use of acetaminophen
- Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
- Lack of reliable telephone facility for contact
- Known or suspected allergy against insulin
- Severe visual impairment
- Severe hearing impairment
- Subject not proficient in English
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03445377
Start Date
July 16 2018
End Date
June 28 2020
Last Update
March 16 2021
Active Locations (1)
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1
Manchester Diabetes Centre, Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL