Diabetes Mellitus
Conditions
Keywords
white coat adherence, continuous glucose monitoring, flash glucose monitoring, hypoglycemia prediction, deep learning algorithm
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALglucose control (Substudy A)
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
DIAGNOSTIC_TESThypoglycemia prediction (Substudy B)
Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Hypoglycemia prediction (for Substudy B) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 01.01.2013 - 31.07.2018; outcome assessed at study end | Time CGM-/FGM sensor has been worn (%) |
| 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) | 01.01.2013 - 31.07.2018; outcome assessed at study end | Coefficient of variation (CV) based on CGM/FGM data |
| 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) | 01.01.2013 - 31.07.2018; outcome assessed at study end | The time with glucose levels \< 3.0 based on CGM/FGM data |
| 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) | 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) |
| 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) | 01.01.2013 - 31.07.2018; outcome assessed at study end | The mean amplitude of glucose excursion assessed by CGM/FGM |
| 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) | 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. |
| 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) | 01.01.2013 - 31.07.2018; outcome assessed at study end | Average and standard deviation glucose levels based on CGM/FGM data |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | 01.01.2013 - 31.07.2018; outcome assessed at study end | Mean of daily differences (MODD) based on CGM/FGM data |
| 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) | 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 |
| 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) | 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 |
| Change of total, basal and bolus insulin dose day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | 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 |
Countries
Switzerland
Outcome results
None listed