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Completed

NCT Number: NCT03898076

Predictive A1c Based on CGM Data Using CGM Data

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sidra Medicine

Doha, Qa, 26999, Qatar

About this study

This is a retrospective analysis. The investigators will de-identify and analyze 120 patients with T1D using Continuous Glucose Monitoring (CGM) system 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 be developed to predict HbA1c in 2-3 months advance based on these 15 days of CGM data. The model is using linear regression, penalized regression (Ridge regression, Lasso regression and Elastic net regression) in combination gradient boosting to calculate predictive A1c

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes
  • Flash glucose Monitoring system

Exclusion criteria

  • Less than 70% od CGM data in the last 90 days.

Treatment and study plan

Flash Glucose Monitoring

Device

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

A1c

Other

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

Predictive A1c

Other

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.

Primary outcomes

  1. The difference of Predictive A1c level from CGM data with Real A1c level from EMR

    Time frame: 3 months

    Difference (%) between Predicted A1c and laboratory A1c from the Electronic Medical Record

Sponsors and collaborators

Lead sponsor

Sidra Medicine

Other

Registry information

Official study title

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

Acronym: A1c

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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