CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Flash Glucose Monitoring +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03898076
NCT03898076N/ACompleted

The Prediction of A1c Based on CGM Data Through Applying Machine Learning Approaches

Sidra Medicine·observational·Posted Apr 1, 2019·Updated Sep 28, 2021

In Brief

An observational study evaluating Flash Glucose Monitoring, A1c, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Introduction. The hemoglobin A1C (HbA1c) reflects the average blood glucose level for last two to three months. Recent advancements in the sensor technology facilitate the daily monitoring of the blood glucose using CGM devices. The future prediction of the HbA1C based on the CGM data holds a critical significance in maintaining long term health of diabetes patients. A higher than normal value of the HbA1c greatly increases the likelihood of diabetes related cardiovascular disease. Goal. The aim this study is to predict the HbA1c in advance by utilizing the CGM data through applying machine learning techniques. The outcomes of this research will assist in improving the health of diabetic patients. Methods. This is a retrospective analysis. The investigators will de-identify and analyze 120 patients with T1D who using CGM sensor for last three months. Past 15 days of CGM data will be analyzed and different glucose variability features such as time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA) will be extracted. A machine learning model will calculate (predict) HbA1c in 2-3 months advance based on these 15 days of CGM data. To evaluate the performance of the proposed prediction model, predicted HbA1c will be compared with the real HbA1c.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesQatar
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartJun 1, 2020
Primary CompletionAug 31, 2020
Study CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.3 years ago

Interventions

Flash Glucose Monitoringdevice

Continuous Glucose Monitoring (CGM) values will be downloaded from CGM device for a period of 90 days.

A1cother

A1c levels will be collected from Hospital EMR prior to CGM data downoad

Predictive A1cother

Predictive A1c will be calculated based on the first 15 days of CGM data using time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA). Predictive A1c will be correlated with actual A1c.