Diabetes Mellitus, Type 2
Conditions
Brief 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. 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.
Interventions
DRUGOral antidiabetetic drugs
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
DRUGBasal insulin
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
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
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Metformin ± other OADs 2. Basal insulin ± OADs 3. 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant invited to consent and consented via e-signature (Yes/No) | 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) | 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) | From week 0 until end of study (week 12) | % of questionnaires and RVs completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time below range (TBR) L2 (below 3.0 mmol/L) | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | % of time. |
| Mean glucose | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | nmol/L. |
| Time in range (TIR) (3.9-10 mmol/L) | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | % of time. |
| Participant with at least 70% heart rate (pulse) data (Yes/No) | From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement | Count of participants. |
| 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) | — |
| Time above range (TAR) (above 10 mmol/L) | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | % of time. |
| Time below range (TBR) L1 (3.0-3.9 mmol/L) | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | % of time. |
Countries
Denmark
Outcome results
None listed