Diabetes Mellitus, Type 2NCT04809311
Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Oral antidiabetetic drugs, Basal insulin and Glucagon-like peptide-1 (GLP-1)
- Type of treatment
- Pill or oral medicine
- How many people
- 156 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Apr 2024to 7 Jan 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes mellitus on different treatment regimens.
Who may be able to join
- Willingness to consent via the e-consent process before any study-related activities takes place (study-related activities are any procedure related to recording of data according to the protocol)
- Male or female, age above or equal to 18 years at the time of signing informed consent
- Diagnosed T2DM for more than 3 months prior to signing the informed consent
- On one of the following treatments for T2DM:
- Metformin ± other OADs
- Basal insulin ± OADs
Show all 11Show fewer
- GLP-1 ± Basal insulin (loose and fixed combination) ± OADs
- Willingness to, and capable of applying and using the study devices
- Willingness to follow study procedures
- Fluent in Danish both oral, reading and in writing
- In possession of a compatible smartphone throughout the study, meaning that the smartphone fulfils the criteria to the operating system for using the devices needed for the study
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any other study investigating diabetes.
- Patients who do not have a blood glucose meter at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fully Decentralised Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Participants With Type 2 Diabetes Mellitus on Different Treatment Regimens
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, everything will be handled without any visits to a hospital or doctor.
For collection of participants' blood glucose values participants will receive two different blood glucose monitors. One where participants cannot see the blood glucose values and one where participants can see the blood glucose values. Participants must wear them consecutively for 2 and 10 weeks, respectively. Further, participants will be asked to self-apply the monitors on their upper arm.
Read more
For collection of participants' activity data participants will receive an activity tracker, which participants will wear on the wrist throughout the study.
The study does not include any study medication and participants will continue the current antidiabetic treatment as prescribed to participants by their own physician. If any questions about the treatment and/or health condition while participating in the trial, participants should consult your own physician If participants are in doubt about what the blood glucose values mean or whether participants should react to the blood glucose values, participants need to contact the research staff or their general practitioner.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Oral antidiabetetic drugs, Basal insulin, Glucagon-like peptide-1 (GLP-1)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral antidiabetetic drugsDrug
During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration
Basal insulinDrug
During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration
Glucagon-like peptide-1 (GLP-1)Drug
During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration
| Study group | Role | What they receive |
|---|---|---|
| Other oral antidiabetic drugs (OADs) ± metformin | Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician Receives: Drug: Oral antidiabetetic drugs | |
| Basal insulin ± OADs | Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician Receives: Drug: Basal insulin | |
| Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs | Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician Receives: Drug: Basal insulin; Drug: Glucagon-like peptide-1 (GLP-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant invited to consent and consented via e-signature (Yes/No)
Measured as count of participants.
Measured: During Screening (Week -2 to week 0 )
Participant with at least 70% unblinded CGM (continuous glucose monitoring) data (Yes/No)
Measured as Count of participants.
Measured: From time of first unblinded CGM measurement until 10 weeks after the time of first unblinded CGM measurement
Participant completion of questionnaires and per protocol planned remote visits (RVs)
% of questionnaires and RVs completed.
Measured: From week 0 until end of study (week 12)
Secondary outcomes (7)
Time in range (TIR) (3.9-10 mmol/L)
% of time.
Measured: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Time above range (TAR) (above 10 mmol/L)
% of time.
Measured: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Time below range (TBR) L1 (3.0-3.9 mmol/L)
% of time.
Measured: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Time below range (TBR) L2 (below 3.0 mmol/L)
% of time.
Measured: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Mean glucose
nmol/L.
Measured: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Coefficient of variation (CV) of glucose measurements
Measured: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Participant with at least 70% heart rate (pulse) data (Yes/No)
Count of participants.
Measured: From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start30 Apr 2024
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809311
- Sponsor's protocol ID
- NN1535-7774
- Other IDs
- U1111-1254-5030
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Decentralised Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Participants With Type 2 Diabetes Mellitus on Different Treatment Regimens
- ClinicalTrials.gov ID
- NCT04809311
- Acronym / sponsor ID
- NN1535-7774
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 22 Mar 2021 (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.
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, everything will be handled without any visits to a hospital or doctor.
For collection of participants' blood glucose values participants will receive two different blood glucose monitors. One where participants cannot see the blood glucose values and one where participants can see the blood glucose values. Participants must wear them consecutively for 2 and 10 weeks, respectively. Further, participants will be asked to self-apply the monitors on their upper arm.
For collection of participants' activity data participants will receive an activity tracker, which participants will wear on the wrist throughout the study.
The study does not include any study medication and participants will continue the current antidiabetic treatment as prescribed to participants by their own physician. If any questions about the treatment and/or health condition while participating in the trial, participants should consult your own physician If participants are in doubt about what the blood glucose values mean or whether participants should react to the blood glucose values, participants need to contact the research staff or their general practitioner.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Other oral antidiabetic drugs (OADs) ± metformin | – | Drug: Oral antidiabetetic drugsPatients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician |
| Basal insulin ± OADs | – | Drug: Basal insulinPatients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician |
| Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs | – | Drug: Basal insulin, Drug: Glucagon-like peptide-1 (GLP-1)Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus on different treatment regimens.
Key inclusion criteria (11 listed)
- Willingness to consent via the e-consent process before any study-related activities takes place (study-related activities are any procedure related to recording of data according to the protocol)
- Male or female, age above or equal to 18 years at the time of signing informed consent
- Diagnosed T2DM for more than 3 months prior to signing the informed consent
- On one of the following treatments for T2DM:
- Willingness to, and capable of applying and using the study devices
Key exclusion criteria (4 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any other study investigating diabetes.
- Patients who do not have a blood glucose meter at home
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 |
|---|---|---|
| Oral antidiabetetic drugsDuring the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice. Approximately 12-week study duration | Drug | Other oral antidiabetic drugs (OADs) ± metformin |
| Basal insulinDuring the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice. Approximately 12-week study duration | Drug | Basal insulin ± OADs, Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs |
| Glucagon-like peptide-1 (GLP-1)During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice. Approximately 12-week study duration | Drug | Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs |
Primary outcome
Participant invited to consent and consented via e-signature (Yes/No)
Time frame: During Screening (Week -2 to week 0 )
Measured as count of participants.
Participant with at least 70% unblinded CGM (continuous glucose monitoring) data (Yes/No)
Time frame: From time of first unblinded CGM measurement until 10 weeks after the time of first unblinded CGM measurement
Measured as Count of participants.
Participant completion of questionnaires and per protocol planned remote visits (RVs)
Time frame: From week 0 until end of study (week 12)
% of questionnaires and RVs completed.
7 secondary outcomes
Time in range (TIR) (3.9-10 mmol/L)
Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Time above range (TAR) (above 10 mmol/L)
Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Time below range (TBR) L1 (3.0-3.9 mmol/L)
Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Time below range (TBR) L2 (below 3.0 mmol/L)
Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Mean glucose
Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Coefficient of variation (CV) of glucose measurements
Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)
Participant with at least 70% heart rate (pulse) data (Yes/No)
Time frame: From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement
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 21 Mar 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
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 11 inclusion and 4 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 21 Mar 2025. 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 Denmark. 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. 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?
Participant invited to consent and consented via e-signature (Yes/No) (time frame: During Screening (Week -2 to week 0 )). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2025.