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Completed

NCT Number: NCT04809311

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Digital/virtual site

Copenhegan, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Metformin ± other OADs
  • Basal insulin ± OADs
  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Participant invited to consent and consented via e-signature (Yes/No)

    Time frame: During Screening (Week -2 to week 0 )

    Measured as count of participants.

  2. Participant with at least 70% unblinded CGM (continuous glucose monitoring) data (Yes/No)

    Time frame: From time of first unblinded CGM measurement until 10 weeks after the time of first unblinded CGM measurement

    Measured as Count of participants.

  3. Participant completion of questionnaires and per protocol planned remote visits (RVs)

    Time frame: From week 0 until end of study (week 12)

    % of questionnaires and RVs completed.

Secondary outcomes

  1. Time in range (TIR) (3.9-10 mmol/L)

    Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)

    % of time.

  2. Time above range (TAR) (above 10 mmol/L)

    Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)

    % of time.

  3. Time below range (TBR) L1 (3.0-3.9 mmol/L)

    Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)

    % of time.

  4. Time below range (TBR) L2 (below 3.0 mmol/L)

    Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)

    % of time.

  5. Mean glucose

    Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)

    nmol/L.

  6. Coefficient of variation (CV) of glucose measurements

    Time frame: From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)

  7. Participant with at least 70% heart rate (pulse) data (Yes/No)

    Time frame: From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement

    Count of participants.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2021
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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