Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Lifestyle
* Drug: Oral antidiabetetic drugs
* Drug: Basal insulin
* Drug: Glucagon-like peptide-1 (GLP-1)
* Drug: Premixed insulin


Participation Criteria
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Eligibility Criteria
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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: Lifestyle intervention plus/minus metformin Other OADs (oral antidiabetic drugs) plus/minus metformin Basal insulin plus/minus OADs GLP-1 plus/minus Basal insulin (loose and fixed combination) plus/minus OADs 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lifestyle intervention ± metformin<br>Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician. | Other: Lifestyle<br>* 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<br>|
| Other oral antidiabetic drugs (OADs) ± metformin<br>Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Drug: Oral antidiabetetic drugs<br>* 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<br>|
| Basal insulin ± OADs<br>Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Drug: Basal insulin<br>* 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<br>|
| Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs<br>Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Drug: Basal insulin<br>* 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<br>Drug: Glucagon-like peptide-1 (GLP-1)<br>* 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<br>|
| Basal + Bolus or premixed insulin ± OADs<br>Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Drug: Basal insulin<br>* 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<br>Drug: Premixed insulin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient attended RV (remote visit) 1 and consented via e-signature | Yes/No | Screening (Week -2) | 
| Patient with at least 70% unblinded FGM (flash glucose monitoring) data | Yes/No | Week 2 to 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range (TIR) (3.9-10 mmol/L) | % of readings | week 2 to 12 | 
| Time above range (TAR) (above 10 mmol/L) | % of readings | week 2 to 12 | 
| Time below range (TBR) L1 (3.0-3.9 mmol/L) | % of readings | week 2 to 12 | 
| Time below range (TBR) L2 (below 3.0 mmol/L) | % of readings | week 2 to 12 | 
| Mean glucose | nmol/L | week 2 to 12 | 
| Coefficient of variation (CV) |  | week 2 to 12 |