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

NCT04809311 | Completed DMC

• 2 other identifiers: NN1535-7774U1111-1254-5030
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• Mean glucose

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

Study Arms (3)

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

Drug: Oral antidiabetetic drugs

Basal insulin ± OADs

Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician

Drug: Basal insulin

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

Drug: Basal insulin; Drug: Glucagon-like peptide-1 (GLP-1)

Interventions

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

Other oral antidiabetic drugs (OADs) ± metformin

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

Basal insulin ± OADs; Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs

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

Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes mellitus on different treatment regimens.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Digital/virtual site

Copenhegan, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: April 30, 2024
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)