Diabetes Mellitus, Type 1
Conditions
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.
Interventions
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.
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.
Sponsors
DexCom, Inc.
Manchester University NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Masking 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.
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 297 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| HbA1c at 8 weeks | 8 weeks | HbA1c at 8 weeks (midway point) |
| Average variation of glucose levels | 8 weeks | Average variation of glucose levels |
| Standard deviation variation of glucose levels | 8 weeks | Standard deviation variation of glucose levels |
| 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). |
| 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 |
| 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 |
| Total daily insulin dose | 8 weeks | Total, basal and bolus insulin dose |
| Coefficient variation of glucose levels | 8 weeks | Coefficient variation of glucose levels |
Countries
United Kingdom
Outcome results
None listed