Clinical trial NCT03445377: Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS
Official title: An Open-label, Single-centre, Randomised, Cross-over Design Feasibility Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Comparison With Self-monitoring of Blood Glucose in Young Adults and Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: DexCom, Inc.
First posted: 2018-02-26
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 297
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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 daily glucose levels either with real-time CGM or SMBG in random order.
Primary purpose: OTHER

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 adults with type 1 diabetes.

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 daily glucose levels either with real-time CGM or SMBG in random order. Subjects will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40 subjects (aiming for 30 completed subjects) aged 16 to 24 years with T1D will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 2 weeks of the first intervention period will be replaced.

Subjects will receive appropriate training in the use of real-time CGM. Subjects will have regular contact with the study team during the study.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of subject's responses in terms of daily diabetes management, diabetes distress and diabetes technology use and acceptance will also be evaluated in this study.

Eligibility criteria: Inclusion Criteria:

1. Age between 16 - 24 years old (inclusive)
2. Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
3. HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment
4. Treated with insulin pump or MDI
5. Has a Smart phone compatible with Dexcom G5 or similar
6. Willingness to wear study devices
7. Willing to follow study specific instructions
8. Literate in English

Exclusion Criteria:

1. Non-type 1 diabetes mellitus including those secondary to chronic disease
2. Any other physical or psychological disease likely to interfere with the normal conduct of the study
3. Untreated celiac disease or hypothyroidism
4. Current or planned users of real-time or flash (Libre) glucose monitoring sensors
5. 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.
6. Regular use of acetaminophen
7. Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
8. 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)
9. Lack of reliable telephone facility for contact
10. Known or suspected allergy against insulin
11. Severe visual impairment
12. Severe hearing impairment
13. Subject not proficient in English

Primary outcomes:
measure: Sensor Glucose readings within target range
timeFrame: 8 weeks
Secondary outcomes:
measure: Sensor Glucose readings below target range
timeFrame: 8 weeks
measure: Sensor Glucose readings above target range
timeFrame: 8 weeks
measure: HbA1c at 8 weeks
timeFrame: 8 weeks
measure: Average variation of glucose levels
timeFrame: 8 weeks
measure: Standard deviation variation of glucose levels
timeFrame: 8 weeks
measure: Coefficient variation of glucose levels
timeFrame: 8 weeks
measure: The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l
timeFrame: 8 weeks
measure: The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)
timeFrame: 8 weeks
measure: AUC of glucose below 3.5mmol/l
timeFrame: 8 weeks
measure: Total daily insulin dose
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Diabetes Centre, Manchester University NHS Foundation Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Hood Thabit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thabit H, Prabhu JN, Mubita W, Fullwood C, Azmi S, Urwin A, Doughty I, Leelarathna L. Use of Factory-Calibrated Real-time Continuous Glucose Monitoring Improves Time in Target and HbA1c in a Multiethnic Cohort of Adolescents and Young Adults With Type 1 Diabetes: The MILLENNIALS Study. Diabetes Care. 2020 Oct;43(10):2537-2543. doi: 10.2337/dc20-0736. Epub 2020 Jul 28.