Clinical trial NCT03545178: Systematic Evaluation of Continuous Glucose Monitoring Data
Official title: Systematic Evaluation of Continuous Glucose Monitoring Data to for the Development of Clinical Solutions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: white coat adherence
continuous glucose monitoring
flash glucose monitoring
hypoglycemia prediction
deep learning algorithm
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 384
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients suffering from diabetes mellitus controlled at our tertiary referral centre using a CGM/FMG device for at least 50% of the time

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: Hypoglycemia prediction (for Substudy B)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary outcomes:
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
Other outcomes:
measure: Change of total, basal and bolus insulin dose day 0-7 compared to day 8-28 prior to consultation (for Substudy A)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
measure: 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)
timeFrame: 01.01.2013 - 31.07.2018; outcome assessed at study end
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital, University of Bern
state: BE
Study officials:
affiliation: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland
name: Thomas Zueger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland
name: Christoph Stettler, Prof.
role: STUDY_DIRECTOR
References: