Systematic Evaluation of Continuous Glucose Monitoring Data

Diabetes Mellitus Clinical Trial

— SECOND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545178
• Other study ID #: 2018-00207
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: July 19, 2019

Study information

• Verified date: August 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• glucose 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 Test:
• hypoglycemia prediction (Substudy B)
Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital, University of Bern	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of total, basal and bolus insulin dose day 0-7 compared to day 8-28 prior to consultation (for Substudy A)	Total, basal and bolus insulin dose based on data of continuous subcutaneous insulin infusion data in patients treated with insulin pumps	01.01.2013 - 31.07.2018; outcome assessed at study end
Other	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)	Duration of periods when sensor glucose values was below 3.0mmol/l for at least 15 minutes	01.01.2013 - 31.07.2018; outcome assessed at study end
Other	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)	Duration of periods when sensor glucose values was above 13.9mmol/l for at least 15 minutes	01.01.2013 - 31.07.2018; outcome assessed at study end
Other	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)	Mean of daily differences (MODD) based on CGM/FGM data	01.01.2013 - 31.07.2018; outcome assessed at study end
Primary	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)	The time spent in the target glucose range from 3.9 to 10.0 mmol/l assessed by CGM/FGM.	01.01.2013 - 31.07.2018; outcome assessed at study end
Primary	Hypoglycemia prediction (for Substudy B)	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?	01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary	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)	The time spent above and below the target glucose (3.9 to 10.0 mmol/l) assessed by CGM/FGM.	01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary	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)	Average and standard deviation glucose levels based on CGM/FGM data	01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary	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 CGM-/FGM sensor has been worn (%)	01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary	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)	Coefficient of variation (CV) based on CGM/FGM data	01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary	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)	The time with glucose levels < 3.0 based on CGM/FGM data	01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary	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)	The time with glucose levels in the significant hyperglycaemia, as based on CGM/FGM (glucose levels > 13.9 mmol/l)	01.01.2013 - 31.07.2018; outcome assessed at study end
Secondary	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)	The mean amplitude of glucose excursion assessed by CGM/FGM	01.01.2013 - 31.07.2018; outcome assessed at study end