Changing Outpatient Diabetes Care With Remote-Patient-Monitoring: A Real World Evidence Study With Pre-Post Comparison

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSteno Diabetes Center Copenhagen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Remote-Patient-Monitoring (RPM)

    Other intervention

    The RPM-system "Steno Detektor" integrated within the EHR-system

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
2

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)

Time frame
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
3

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.

Time frame
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).

Secondary outcomes

1

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.

Time frame
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
2

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.

Time frame
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
3

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.

Time frame
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
4

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.

Time frame
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).

Other outcomes

Sponsors and contacts

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