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HbA1c Prediction Model in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HbA1c prediction
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Blood Glucose Self-Monitoring, HbA1c Prediction Model, Ridge Regression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HbA1c prediction model group

Conventional treatment group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in measured HbA1c from baseline to 24 weeks

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2023
Last Updated
April 9, 2023
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05824286
Brief Title
HbA1c Prediction Model in Patients With Type 2 Diabetes
Official Title
Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Blood Glucose Self-Monitoring, HbA1c Prediction Model, Ridge Regression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HbA1c prediction model group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment group
Arm Type
No Intervention
Arm Description
Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c.
Intervention Type
Other
Intervention Name(s)
HbA1c prediction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in measured HbA1c from baseline to 24 weeks
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in measured HbA1c from baseline to 12 weeks
Time Frame
12 weeks
Title
The percentages of participants with HbA1c less than 7.0% at 12 weeks
Time Frame
12 weeks
Title
The percentages of participants with HbA1c less than 7.0% at 24 weeks
Time Frame
24 weeks
Title
Change in weight from baseline to 24 weeks
Time Frame
24 weeks
Title
The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study
Time Frame
24 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Xianghai, Prof.
Phone
010-88324371
Email
xianghai_zhou@163.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Chongqing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Xianghai

12. IPD Sharing Statement

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HbA1c Prediction Model in Patients With Type 2 Diabetes

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