Virtual Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Patients With Type 2 Diabetes Mellitus on Different Treatment Regimens

NN1535-7774

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. We will ask participants to keep an electronic diary of the timing of the meal- and medication intake through two shorter periods of the study. On a voluntary basis, participants can choose to donate a saliva sample for the purpose of genetic research in diabetes patients. 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.

2024-03-18

2024-10-14

2024-10-14

Not yet recruiting

500

Inclusion Criteria: * Willingness to consent via the e-consent process before any study-related activities (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 (type 2 diabetes mellitus) for at least one month prior to signing the informed consent * On one of the following treatments for T2DM: 1. Lifestyle intervention plus/minus metformin 2. Other OADs (oral antidiabetic drugs) plus/minus metformin 3. Basal insulin plus/minus OADs 4. GLP-1 plus/minus Basal insulin (loose and fixed combination) plus/minus OADs 5. Basal plus Bolus or premixed insulin plus/minus OADs * Willingness to, and capable of, applying and use the study devices * Willingness to follow study procedures * Fluent in Danish both oral, reading and in writing * In possession of a suitable smartphone throughout the study, meaning that the smartphone fulfils the criteria to the operating system for using the devices needed for the study (refer to the specifications in device manual). 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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

2024-02-23