Inselspital, Bern University Hospital, University of Bern
Bern, Canton of Bern, 3010, Switzerland
NCT Number: NCT03545178
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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Notify Me16 year and older
All sexes
Observational
Bern, Canton of Bern, 3010, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model
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.
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?
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.
Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end
Average and standard deviation glucose levels based on CGM/FGM data
Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end
Time CGM-/FGM sensor has been worn (%)
Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end
Coefficient of variation (CV) based on CGM/FGM data
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
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)
Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end
The mean amplitude of glucose excursion assessed by CGM/FGM
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
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
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
Time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end
Mean of daily differences (MODD) based on CGM/FGM data
Insel Gruppe AG, University Hospital Bern
Other
Systematic Evaluation of Continuous Glucose Monitoring Data to for the Development of Clinical Solutions
Acronym: SECOND
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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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