HbA1c Prediction Model in Patients With Type 2 Diabetes

Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes

Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: HbA1c prediction

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhou Xianghai, Prof.; Phone Number: 010-88324371; Email: xianghai_zhou@163.com

Study Locations

• China
  • Chongqing
    • Beijing, Chongqing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Zhou Xianghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years old;
• Diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; The study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks;
• Have HbA1c results within 4 weeks, and the range was 7.5-11%;
• Willing and able to conduct self-glucose monitoring;
• Have not participated in any other research program in the past 4 weeks.

Exclusion Criteria:

• Type 1 diabetes mellitus;
• Severe hypoglycemia ≥1 time or fasting C-peptide ≤0.80 ng/mL in the past 6 months;
• Diabetic ketosis in the last 1 week;
• Oral or inhaled corticosteroids for more than 14 days within the last 8 weeks;
• Anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis;
• Pregnancy or breastfeeding;
• Receiving chemotherapy or radiation therapy;
• Have a severe mental illness and cannot complete the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HbA1c prediction model group; HbA1c was predicted every month based on self-monitoring blood glucose for patients in HbA1c prediction model group. Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin and predicted HbA1c every month.	Other: HbA1c prediction; HbA1c prediction model was developed based on fasting capillary blood glucose and postprandial capillary blood glucose from self-monitoring blood glucose. Since HbA1c was measured once every 3 month, self-monitoring blood glucose records were transferred to predicted HbA1c by prediction model every month.
No Intervention: Conventional treatment group; Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in measured HbA1c from baseline to 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in measured HbA1c from baseline to 12 weeks	12 weeks
The percentages of participants with HbA1c less than 7.0% at 12 weeks	12 weeks
The percentages of participants with HbA1c less than 7.0% at 24 weeks	24 weeks
Change in weight from baseline to 24 weeks	24 weeks
The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study	24 weeks

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Blood Glucose Self-Monitoring; HbA1c Prediction Model; Ridge Regression
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RDL2022-30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No