Diabetes Mellitus, Type 1MILLENNIALSNCT03445377
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS
A study testing Real-time continuous glucose monitoring and Self-monitoring of blood glucose in people with Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years to 297 months
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Real-time continuous glucose monitoring and Self-monitoring of blood glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2018to 28 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years to 297 months
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Diabetes Centre, Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Real-time continuous glucose monitoring, Self-monitoring of blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time continuous glucose monitoringDevice
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 glucoseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-time continuous glucose monitoring | Active comparator | 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. Receives: Device: Real-time continuous glucose monitoring |
| Self-monitoring of blood glucose | Placebo comparator | 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. Receives: Device: Self-monitoring of blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (10)
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).
Measured: 8 weeks
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).
Measured: 8 weeks
HbA1c at 8 weeks
HbA1c at 8 weeks (midway point)
Measured: 8 weeks
Average variation of glucose levels
Average variation of glucose levels
Measured: 8 weeks
Standard deviation variation of glucose levels
Standard deviation variation of glucose levels
Measured: 8 weeks
Coefficient variation of glucose levels
Coefficient variation of glucose levels
Measured: 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 < 3.5 mmol/l , 3.0 and <2.8 mmol/l
Measured: 8 weeks
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)
Measured: 8 weeks
AUC of glucose below 3.5mmol/l
AUC (Area under the Curve) of glucose below 3.5mmol/l
Measured: 8 weeks
Total daily insulin dose
Total, basal and bolus insulin dose
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start16 Jul 2018
- Primary completion28 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Hood Thabit, MD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445377
- Sponsor's protocol ID
- R04778
- Acronym
- MILLENNIALS
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous participant data such as primary and secondary outcome data will be made available to researchers working directly on the study only.
Publications
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.
PubMed 32723843
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03445377
- Acronym / sponsor ID
- MILLENNIALS / R04778
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- DexCom, Inc.
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 28 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real-time continuous glucose monitoring | Active comparator | Device: Real-time continuous glucose monitoringSubjects 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. |
| Self-monitoring of blood glucose | Placebo comparator | Device: Self-monitoring of blood glucoseSubjects 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. |
Who may qualify
- Ages
- 16 years to 297 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time continuous glucose monitoringSubjects 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. | Device | Real-time continuous glucose monitoring |
| Self-monitoring of blood glucoseSubjects 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. | Device | Self-monitoring of blood glucose |
Primary outcome
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).
10 secondary outcomes
Sensor Glucose readings below target range
Time frame: 8 weeks
Sensor Glucose readings above target range
Time frame: 8 weeks
HbA1c at 8 weeks
Time frame: 8 weeks
Average variation of glucose levels
Time frame: 8 weeks
Standard deviation variation of glucose levels
Time frame: 8 weeks
Coefficient variation of glucose levels
Time frame: 8 weeks
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 in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)
Time frame: 8 weeks
AUC of glucose below 3.5mmol/l
Time frame: 8 weeks
Total daily insulin dose
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Derived from this study: PubMed 32723843Thabit 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.
- Individual participant dataSharing planned: Yes. Anonymous participant data such as primary and secondary outcome data will be made available to researchers working directly on the study only.
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hood Thabit, MD principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time continuous glucose monitoring and Self-monitoring of blood glucose in people with Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor Glucose readings within target range (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.