NCT04809311

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
DRUG	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
DRUG	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

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2021-03-22
• Last updated: 2025-03-21

Locations

1 site across 1 country: Denmark