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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04809311
• Other study ID #: NN1535-7774
• Secondary ID: U1111-1254-5030
• Status: Not yet recruiting
• Start date: March 18, 2024
• Est. completion date: October 14, 2024

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 14, 2024
• Est. primary completion date: October 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Lifestyle intervention plus/minus metformin

2. Other OADs (oral antidiabetic drugs) plus/minus metformin

3. Basal insulin plus/minus OADs

4. GLP-1 plus/minus Basal insulin (loose and fixed combination) plus/minus OADs

5. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Lifestyle
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:
• 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
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
• Premixed 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient attended RV (remote visit) 1 and consented via e-signature	Yes/No	Screening (Week -2)
Primary	Patient with at least 70% unblinded FGM (flash glucose monitoring) data	Yes/No	Week 2 to 12
Secondary	Time in range (TIR) (3.9-10 mmol/L)	% of readings	week 2 to 12
Secondary	Time above range (TAR) (above 10 mmol/L)	% of readings	week 2 to 12
Secondary	Time below range (TBR) L1 (3.0-3.9 mmol/L)	% of readings	week 2 to 12
Secondary	Time below range (TBR) L2 (below 3.0 mmol/L)	% of readings	week 2 to 12
Secondary	Mean glucose	nmol/L	week 2 to 12
Secondary	Coefficient of variation (CV)		week 2 to 12