HbA1c Prediction Model in Patients With Type 2 Diabetes

NCT05824286 | Unknown

• 1 other identifier: RDL2022-30
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Blood Glucose Self-Monitoring; HbA1c Prediction Model; Ridge Regression

Outcome Measures

Primary Outcomes (1)

• Change in measured HbA1c from baseline to 24 weeks

  24 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

HbA1c prediction model group

EXPERIMENTAL

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

Conventional treatment group

NO INTERVENTION

Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c.

Interventions

HbA1c prediction OTHER

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.

HbA1c prediction model group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Ch, 100044, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Zhou Xianghai, Prof.

CONTACT

010-88324371; xianghai_zhou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 21, 2023
• Study Start: January 4, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

CN (1)