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Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments 156 Remote Virtual

Completed
Clinical Trial NCT04809311 was an observational study for Diabetes Mellitus, Type 2 that is now completed. The study started on 30 April 2024, with plans to enroll 156 participants. Led by Novo Nordisk A/S, the expected completion date was 7 January 2025. The latest data from ClinicalTrials.gov was last updated on 21 March 2025.
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, e...Show More
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

Conditions
Diabetes Mellitus, Type 2
Other Study IDs
  • NN1535-7774
  • U1111-1254-5030 (Other Identifier) (World Health Organization (WHO))
NCT ID Number
NCT04809311
Start Date (Actual)
2024-04-30
Last Update Posted
2025-03-21
Completion Date (Estimated)
2025-01-07
Enrollment (Estimated)
156
Study Type
Observational
Status
Completed
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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
Oral 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
Basal insulin ± OADs
Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician
Basal 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
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
Basal 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
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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)
% 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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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

  • 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
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No contact data.
1 Study Locations in 1 Countries
Digital/virtual site, Copenhegan, Denmark