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Clinical Trial Details

Trial ID: L6859
Source ID: NCT04809311
Associated Drug: Oral Antidiabetetic Drugs
Title: Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Oral antidiabetetic drugs|DRUG: Basal insulin|DRUG: Glucagon-like peptide-1 (GLP-1)
Outcome Measures: Primary: 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: Time in range (TIR) (3.9-10 mmol/L), % of time., 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), % of time., 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), % of time., 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), % of time., From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)|Mean glucose, nmol/L., From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)|Coefficient of variation (CV) of glucose measurements, From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12)|Participant with at least 70% heart rate (pulse) data (Yes/No), Count of participants., From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 156
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-04-30
Completion Date: 2025-01-07
Results First Posted:
Last Update Posted: 2025-03-21
Locations: Digital/virtual site, Copenhegan, Denmark
URL: https://clinicaltrials.gov/show/NCT04809311