Other Clinical Trial - Predictive A1c Based on CGM Data Using CGM Data

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus, Type 1

Clinical Trial Details

NCT number	NCT03898076
Study type	Observational
Source	Sidra Medical and Research Center
Contact
Status	Completed
Phase
Start date	June 1, 2020
Completion date	December 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04030091` - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus	Phase 4
Terminated	`NCT03605329` - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS	N/A
Completed	`NCT01696266` - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting	`NCT06050642` - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.	N/A
Completed	`NCT05107544` - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes	N/A
Recruiting	`NCT04443153` - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes	N/A
Completed	`NCT04521634` - Glycaemic Variability in Acute Stroke
Completed	`NCT04569994` - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes	Phase 1
Completed	`NCT04089462` - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study	N/A
Completed	`NCT03143816` - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study	Phase 4
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A
Completed	`NCT04042207` - Diabeloop for Highly Unstable Type 1 Diabetes	N/A
Not yet recruiting	`NCT06068205` - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting	`NCT05909800` - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.	Phase 2
Active, not recruiting	`NCT04974528` - Afrezza® INHALE-1 Study in Pediatrics	Phase 3
Completed	`NCT04530292` - Home Intervention and Social Precariousness in Childhood Diabetes	N/A
Recruiting	`NCT05428943` - OPT101 in Type 1 Diabetes Patients	Phase 1
Recruiting	`NCT03988764` - Monogenic Diabetes Misdiagnosed as Type 1
Completed	`NCT05597605` - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Predictive A1c Based on CGM Data Using CGM Data — A1c

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms