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Status unknownNCT05824286Updated Apr 21, 2023

HbA1c Prediction Model in Patients With Type 2 Diabetes

An interventional study of HbA1c prediction in Diabetes Mellitus, Type 2, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2023, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Blood Glucose Self-Monitoring
  • HbA1c Prediction Model
  • Ridge Regression
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • No intervention
    Conventional treatment group

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

Interventions

  • OtherHbA1c 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.

06

What researchers measure

Primary outcomes

  1. Change in measured HbA1c from baseline to 24 weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Change in measured HbA1c from baseline to 12 weeks

    Time frame: 12 weeks

  2. The percentages of participants with HbA1c less than 7.0% at 12 weeks

    Time frame: 12 weeks

  3. The percentages of participants with HbA1c less than 7.0% at 24 weeks

    Time frame: 24 weeks

  4. Change in weight from baseline to 24 weeks

    Time frame: 24 weeks

  5. The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Peking University People's Hospital
    Beijing, Chongqing 100044, China
    • Zhou Xianghai · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05824286
Lead sponsor
Peking University People's Hospital
Responsible party
Xianghai Zhou (Prof., Peking University People's Hospital) — Principal investigator
First posted
Apr 21, 2023
Start date
Jan 4, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Apr 21, 2023

Study contacts

Zhou Xianghai, Prof.
Contact
xianghai_zhou@163.com
010-88324371

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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