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Completed

NCT Number: NCT05409391

Insulin Titration System Based on Deep Learning

This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Zhongshan Hospital Fudan University

Shanghai, China

About this study

The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin. After screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the Insulin Titration System Based on Deep Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than 10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes
  • age of 18-75 years
  • HbA1c between 7.0% and 11.0%.

Exclusion criteria

  • subjects with acute complications of diabetes, such as ketoacidosis or hyperglycemic hyperosmolar state;
  • BMI ≥ 45kg/m2;
  • women who are pregnant or breast-feeding;
  • subjects with severe cardiac, hepatic, renal diseases; subjects with any psychiatric or psychological diseases;
  • subjects with severe edema, infections or peripheral circulation disorders, receiving surgery during hospitalization;
  • subjects who could not comply with the protocol

Treatment and study plan

Insulin Titration System

Device

A noval insulin titration system, which is based on deep learning

Primary outcomes

  1. mean daily blood glucose concentration

    Time frame: 5 days

    For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. The primary outcome is the difference in glycemia control as measured by mean daily blood glucose concentration during the intervention period.

Secondary outcomes

  1. glucose concentration in target range (TIR) of 3.9-10.0 mmol/L

    Time frame: 5 days

    TIR measured by CGM and Capillary glucose measurements, respectively

  2. glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L)

    Time frame: 5 days

    TAR measured by CGM and Capillary glucose measurements, respectively

  3. glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L)

    Time frame: 5 days

    TBR measured by CGM and Capillary glucose measurements, respectively

  4. glycemic variability

    Time frame: 5 days

    glycemic variability measured by CGM and Capillary glucose measurements, respectively

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Study to Assess the Efficacy and Safety of Insulin Titration System Based on Deep Learning on Glucose Control in Type 2 Diabetes Mellitus Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Jun 7, 2023

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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