Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS

Diabetes Mellitus, Type 1 Clinical Trial

— MILLENNIALS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445377
• Other study ID #: R04778
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: June 28, 2020

Study information

• Verified date: March 2021
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 28, 2020
• Est. primary completion date: June 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 297 Months

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Real-time continuous glucose monitoring
Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete.
• Self-monitoring of blood glucose
Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete.

Locations

Country	Name	City	State
United Kingdom	Manchester Diabetes Centre, Manchester University NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	DexCom, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensor Glucose readings within target range	Time spent in the target range of 3.9 to 10mmol/l based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).	8 weeks
Secondary	Sensor Glucose readings below target range	Time spent with glucose levels below 3.9 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).	8 weeks
Secondary	Sensor Glucose readings above target range	Time spent with glucose levels above 10.0 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).	8 weeks
Secondary	HbA1c at 8 weeks	HbA1c at 8 weeks (midway point)	8 weeks
Secondary	Average variation of glucose levels	Average variation of glucose levels	8 weeks
Secondary	Standard deviation variation of glucose levels	Standard deviation variation of glucose levels	8 weeks
Secondary	Coefficient variation of glucose levels	Coefficient variation of glucose levels	8 weeks
Secondary	The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l	The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l	8 weeks
Secondary	The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)	The time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)	8 weeks
Secondary	AUC of glucose below 3.5mmol/l	AUC (Area under the Curve) of glucose below 3.5mmol/l	8 weeks
Secondary	Total daily insulin dose	Total, basal and bolus insulin dose	8 weeks