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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)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Real-time continuous glucose monitoring
Self-monitoring of blood glucose
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

16 Years - 297 Months (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manchester Diabetes Centre, Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Real-time continuous glucose monitoring

Self-monitoring of blood glucose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
HbA1c at 8 weeks
HbA1c at 8 weeks (midway point)
Average variation of glucose levels
Average variation of glucose levels
Standard deviation variation of glucose levels
Standard deviation variation of glucose levels
Coefficient variation of glucose levels
Coefficient variation of glucose levels
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
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)
AUC of glucose below 3.5mmol/l
AUC (Area under the Curve) of glucose below 3.5mmol/l
Total daily insulin dose
Total, basal and bolus insulin dose

Full Information

First Posted
February 8, 2018
Last Updated
March 15, 2021
Sponsor
Manchester University NHS Foundation Trust
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03445377
Brief Title
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
June 28, 2020 (Actual)
Study Completion Date
June 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
DexCom, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time continuous glucose monitoring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Self-monitoring of blood glucose
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Real-time continuous glucose monitoring
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Self-monitoring of blood glucose
Intervention Description
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 Measure Information:
Title
Sensor Glucose readings within target range
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Sensor Glucose readings below target range
Description
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).
Time Frame
8 weeks
Title
Sensor Glucose readings above target range
Description
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).
Time Frame
8 weeks
Title
HbA1c at 8 weeks
Description
HbA1c at 8 weeks (midway point)
Time Frame
8 weeks
Title
Average variation of glucose levels
Description
Average variation of glucose levels
Time Frame
8 weeks
Title
Standard deviation variation of glucose levels
Description
Standard deviation variation of glucose levels
Time Frame
8 weeks
Title
Coefficient variation of glucose levels
Description
Coefficient variation of glucose levels
Time Frame
8 weeks
Title
The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l
Description
The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l
Time Frame
8 weeks
Title
The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)
Description
The time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)
Time Frame
8 weeks
Title
AUC of glucose below 3.5mmol/l
Description
AUC (Area under the Curve) of glucose below 3.5mmol/l
Time Frame
8 weeks
Title
Total daily insulin dose
Description
Total, basal and bolus insulin dose
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
297 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 16 - 24 years old (inclusive) Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment Treated with insulin pump or MDI Has a Smart phone compatible with Dexcom G5 or similar Willingness to wear study devices Willing to follow study specific instructions Literate in English Exclusion Criteria: Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease likely to interfere with the normal conduct of the study Untreated celiac disease or hypothyroidism Current or planned users of real-time or flash (Libre) glucose monitoring sensors 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. Regular use of acetaminophen Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement 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) Lack of reliable telephone facility for contact Known or suspected allergy against insulin Severe visual impairment Severe hearing impairment Subject not proficient in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hood Thabit, MD
Organizational Affiliation
Manchester University NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester Diabetes Centre, Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymous participant data such as primary and secondary outcome data will be made available to researchers working directly on the study only.
IPD Sharing Time Frame
Data will be available within 1 year at the end of study
IPD Sharing Access Criteria
Only individuals granted access will be able to view confidential anonymised data from the study.
Citations:
PubMed Identifier
32723843
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.
Results Reference
derived

Learn more about this trial

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

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