About this trial
The goal of this observational pre-post study is to evaluate a remote-patient-monitoring-system (RPM-system) integrated within an electronic health record (EHR) system in a real world cohort of approximately 12.000 people with diabetes in an outpatient care setting. The main question it aims to answer is:
Whether glycemic outcomes following integration of the RPM system into the EHR over a two-year period are non-inferior compared with outcomes observed prior to an ambulatory care restructuring (including a prototype of the RPM-system) in October 2024.
Participants are included in the RPM-system as part of their regular medical care for diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All people with active clinical care at SDCC during each period and thereby included in the RPM.
Disqualifiers
All people without active clinical care at SDCC during each period.
Trial population
The study population is a dynamic cohort: Participants contribute data until termination of their care at SDCC (e.g., transfer to GP/other hospital). This marks the end of the observation window for that specific participant within the population.
Trial design
Cohort
Prospective
Treatments tested in this trial
Remote-Patient-Monitoring (RPM)
Other interventionThe RPM-system "Steno Detektor" integrated within the EHR-system
Treatment groups
Trial outcomes
Primary outcomes
Children: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Children are defined as age below 18 years of age. Change from PRE to POST period in a CGM endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR) TAR is defined as percentage of time spent with a blood glucose \>10 mmol/L, and TBR is defined as level 2 TBR (percentage of time spent with a blood glucose \<3.0 mmol/L)
Adults with Type 1 diabetes: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Adults are defined as age equal to or above 18 years of age. Change from PRE to POST period in a CGM endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR). TAR is defined as percentage of time spent with a blood glucose \>10 mmol/L, and TBR is defined as level 2 TBR (percentage of time spent with a blood glucose \<3.0 mmol/L)
Adults with Type 2-diabetes: HbA1c (mmol/L)
Adults are defined as age equal to or above 18 years of age. Change in HbA1c (mmol/L) from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
Secondary outcomes
Children: Rate of diabetes related hospitalisations or prehospital contacts.
Children are defined as age below 18 years of age. Diagnoses are based on ICD-10 diagnoses of Hypoglycemia, Diabetic Ketoacidosis and Hyperglycemia.
Children: HbA1c (mmol/L).
Children are defined as age below 18 years of age. Change in HbA1c (mmol/L) from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
Adults with Type 1 diabetes: Rate of diabetes related hospitalisations or prehospital contacts.
Adults are defined as age equal to or above 18 years of age. Diagnoses are based on ICD-10 diagnoses of Hypoglycemia, Diabetic Ketoacidosis, Hyperglycemia and Hyperosmolar hyperglycaemic state.
Adults with Type 1 diabetes: HbA1c (mmol/L).
Adults are defined as age equal to or above 18 years of age. Change in HbA1c (mmol/L) from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
Sponsors and contacts
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