Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS (MILLENNIALS)
Diabetes Mellitus, Type 1
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Manchester Diabetes Centre, Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Real-time continuous glucose monitoring
Self-monitoring of blood glucose
Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. Training on the use of DEXCOM G5 or similar will be provided by the research team. Competency on the use of the system will be evaluated. Participants will be advised to use real-time CGM continuously for the next 8 weeks. At the end of the first intervention, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed.
Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. During the Control Period, masked CGM will be applied for one week, during Week 1, 4 and 8. At the end of this, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed.