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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Self-monitoring of blood glucose; Device: Real-time continuous glucose monitoring

• Registration Number: NCT03445377
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Study Start: 2018-07-16
• Primary Completion: 2020-06-28
• Study Completion: 2020-06-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Self-monitoring of blood glucose	Self-monitoring of blood glucose	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.
Real-time continuous glucose monitoring	Real-time continuous glucose monitoring	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.

Primary Outcome Measures

Name	Time	Method
Sensor Glucose readings within target range	8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l	8 weeks	The time with sensor glucose levels \< 3.5 mmol/l , 3.0 and \<2.8 mmol/l
Sensor Glucose readings above target range	8 weeks	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).
Average variation of glucose levels	8 weeks	Average variation of glucose levels
Coefficient variation of glucose levels	8 weeks	Coefficient variation of glucose levels
The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)	8 weeks	The time with glucose levels in the significant hyperglycaemia (glucose levels \> 16.7 mmol/l)
AUC of glucose below 3.5mmol/l	8 weeks	AUC (Area under the Curve) of glucose below 3.5mmol/l
HbA1c at 8 weeks	8 weeks	HbA1c at 8 weeks (midway point)
Standard deviation variation of glucose levels	8 weeks	Standard deviation variation of glucose levels
Total daily insulin dose	8 weeks	Total, basal and bolus insulin dose
Sensor Glucose readings below target range	8 weeks	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).

Trial Locations

Locations (1)

Manchester Diabetes Centre, Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom