ClinicalTrials.Veeva

Menu

Predictive A1c Based on CGM Data Using CGM Data

S

Sidra Medicine

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Other: A1c
Device: Flash Glucose Monitoring
Other: Predictive A1c

Study type

Observational

Funder types

Other

Identifiers

NCT03898076
2019003271

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 1 Diabetes
  • Flash glucose Monitoring system

Exclusion criteria

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems