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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1254-5030 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Basal insulin ± OADs | Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral antidiabetetic drugs | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant invited to consent and consented via e-signature (Yes/No) | Measured as count of participants. | 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. | 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. | From week 0 until end of study (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range (TIR) (3.9-10 mmol/L) | % of time. | 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) |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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Patients with type 2 diabetes mellitus on different treatment regimens.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digital/virtual site | Copenhegan | Denmark |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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| Basal insulin | 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 |
|
| 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 |
|
% of time.
| 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. | 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. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
| Mean glucose | nmol/L. | 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 | 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. | From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement |
| D004700 | Endocrine System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |