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Completed

NCT Number: NCT03545178

Systematic Evaluation of Continuous Glucose Monitoring Data

This study retrospectively evaluates continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) data and pursues two main objectives: First, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat adherence"). Second, the investigators use the collected CGM and FGM data to develop a hypoglycemia prediction model.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Bern University Hospital, University of Bern

Bern, Canton of Bern, 3010, Switzerland

About this study

Substudy A.) Presence of white coat adherence in diabetic patients:

The investigators aim at evaluating the existence of a so called "white coat adherence" with regard to diabetes control, which means that blood-glucose is better controlled in the days immediately prior to a consultation at the diabetes clinic compared to the time-period further back. To analyse this phenomenon, the investigators use continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) of diabetic patients and compare CGM-/FGM data of the last three days prior to the consultation with the CGM-/FGM data of the days 4-28 prior to the consultation, as well as the last seven days prior to the consultation with days 8-28 prior to the consultation.

Substudy B.) Retrospective data collection for the development and evaluation of a hypoglycemia prediction model:

Scope of the study is to use retrospective data for training and evaluation of a deep recurrent neural network based system for predicting the onset of hypoglycemic event at least 20 min ahead in time. The study aims to: I, assess the ability of deep learning algorithm to predict hypoglycemic events using the data collected during substudy 1. II, assess the ability of global model to be personalized using the data collected during sub-study 1. III, investigate the amount of "history" to be involved to achieve maximum performance in terms of prediction ability. IV, develop a global model, which can be easily further personalized to achieve optimum prediction performance per patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus
  • CGM and/or FGM available for at least 50% of the time in last 4 weeks before consultation
  • Written informed general consent for the retrospective analysis of data

Exclusion criteria

  • Pregnancy

Treatment and study plan

glucose control (Substudy A)

Behavioral

Comparison of glucose values during days 0 - 3 with days 4 - 28 and 0 - 7 with days 8 - 28 before a medical consultation at the diabetes clinic in patients suffering from diabetes and wearing a continuous glucose monitoring and/or flash glucose monitoring device

hypoglycemia prediction (Substudy B)

Diagnostic Test

Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model

Primary outcomes

  1. Change of time in target glucose range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    The time spent in the target glucose range from 3.9 to 10.0 mmol/l assessed by CGM/FGM.

  2. Hypoglycemia prediction (for Substudy B)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Proportion of times a deep learning based algorithm can predict a hypoglycemic event (BG <4.0 mmol/l) at least 20 min ahead in time?

Secondary outcomes

  1. Change of time above and below glucose target range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    The time spent above and below the target glucose (3.9 to 10.0 mmol/l) assessed by CGM/FGM.

  2. Change of average and standard deviation glucose day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Average and standard deviation glucose levels based on CGM/FGM data

  3. Sensor wearing time day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Time CGM-/FGM sensor has been worn (%)

  4. Change of coefficient of variation (CV) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Coefficient of variation (CV) based on CGM/FGM data

  5. Change of time in hypoglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    The time with glucose levels < 3.0 based on CGM/FGM data

  6. Change of time in hyperglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    The time with glucose levels in the significant hyperglycaemia, as based on CGM/FGM (glucose levels > 13.9 mmol/l)

  7. Change of mean amplitude of glucose excursion (MAGE) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    The mean amplitude of glucose excursion assessed by CGM/FGM

Other outcomes

  1. Change of total, basal and bolus insulin dose day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Total, basal and bolus insulin dose based on data of continuous subcutaneous insulin infusion data in patients treated with insulin pumps

  2. Change of periods with glucose below 3.0mmol/l for at least 15 minutes day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Duration of periods when sensor glucose values was below 3.0mmol/l for at least 15 minutes

  3. Change of periods with glucose above 13.9mmol/l for at least 15 minutes day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Duration of periods when sensor glucose values was above 13.9mmol/l for at least 15 minutes

  4. Change of mean of daily differences (MODD) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end

    Mean of daily differences (MODD) based on CGM/FGM data

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Systematic Evaluation of Continuous Glucose Monitoring Data to for the Development of Clinical Solutions

Acronym: SECOND

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2018
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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