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

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ClinicalTrials.gov Identifier: NCT03445377
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Real-time continuous glucose monitoring Device: Self-monitoring of blood glucose Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
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.
Primary Purpose: Other
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
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: 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.
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.

Placebo Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. Sensor Glucose readings within target range [ Time Frame: 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 :
  1. Sensor Glucose readings below target range [ Time Frame: 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).

  2. Sensor Glucose readings above target range [ Time Frame: 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).

  3. HbA1c at 8 weeks [ Time Frame: 8 weeks ]
    HbA1c at 8 weeks (midway point)

  4. Average variation of glucose levels [ Time Frame: 8 weeks ]
    Average variation of glucose levels

  5. Standard deviation variation of glucose levels [ Time Frame: 8 weeks ]
    Standard deviation variation of glucose levels

  6. Coefficient variation of glucose levels [ Time Frame: 8 weeks ]
    Coefficient variation of glucose levels

  7. The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l [ Time Frame: 8 weeks ]
    The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l

  8. The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) [ Time Frame: 8 weeks ]
    The time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)

  9. AUC of glucose below 3.5mmol/l [ Time Frame: 8 weeks ]
    AUC (Area under the Curve) of glucose below 3.5mmol/l

  10. Total daily insulin dose [ Time Frame: 8 weeks ]
    Total, basal and bolus insulin dose



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Ages Eligible for Study:   16 Years to 297 Months   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445377


Locations
United Kingdom
Manchester Diabetes Centre, Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Manchester University NHS Foundation Trust
DexCom, Inc.
Investigators
Principal Investigator: Hood Thabit, MD Manchester University NHS Foundation Trust

Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03445377     History of Changes
Other Study ID Numbers: R04778
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous participant data such as primary and secondary outcome data will be made available to researchers working directly on the study only.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 1 year at the end of study
Access Criteria: Only individuals granted access will be able to view confidential anonymised data from the study.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases