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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Lifestyle; Drug: Oral antidiabetetic drugs; Drug: Basal insulin; Drug: Glucagon-like peptide-1 (GLP-1); Drug: Premixed insulin

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes mellitus on different treatment regimens.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lifestyle intervention ± metformin; Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician.	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
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; 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	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
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; 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
Basal + Bolus or premixed insulin ± OADs; Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician	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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient attended RV (remote visit) 1 and consented via e-signature	Yes/No	Screening (Week -2)
Patient with at least 70% unblinded FGM (flash glucose monitoring) data	Yes/No	Week 2 to 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range (TIR) (3.9-10 mmol/L)	% of readings	week 2 to 12
Time above range (TAR) (above 10 mmol/L)	% of readings	week 2 to 12
Time below range (TBR) L1 (3.0-3.9 mmol/L)	% of readings	week 2 to 12
Time below range (TBR) L2 (below 3.0 mmol/L)	% of readings	week 2 to 12
Mean glucose	nmol/L	week 2 to 12
Coefficient of variation (CV)		week 2 to 12

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): March 18, 2024
• Primary Completion (Estimated): October 14, 2024
• Study Completion (Estimated): October 14, 2024

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Insulin; Insulin, Globin Zinc; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: NN1535-7774; U1111-1254-5030 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No