HbA1c Prediction Model in Patients With Type 2 Diabetes

Sponsor

Peking University People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05824286

Collaborator

(none)

150

Enrollment

Location

Arms

23.9

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Other: HbA1c prediction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 4, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in measured HbA1c from baseline to 24 weeks [24 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing	Chongqing	China	100044

Sponsors and Collaborators

Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xianghai Zhou, Prof., Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT05824286

Other Study ID Numbers:

RDL2022-30

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xianghai Zhou, Prof., Peking University People's Hospital

Blood Glucose Self-Monitoring

HbA1c Prediction Model

Ridge Regression

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 21, 2023