Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

542 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Changing the Natural History of Type 2 Diabetes ("CHANGE" Study)

NCT05040087

Type 2 Diabetes

ACTIVE_NOT_RECRUITING NA

A1c Discordance in Diabetes Patients

NCT01213277

Diabetes Mellitus

SUSPENDED NA

HbA1c Prediction Model in Patients With Type 2 Diabetes

NCT05824286

Diabetes Mellitus, Type 2

UNKNOWN NA

Arterial Stiffness and Complication Risk in Type 2 Diabetes

NCT02001532

Diabetes Mellitus, Type 2 Diabetes Complications Diabetic Angiopathies +1 more

COMPLETED

Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis

NCT07111416

Type 2 Diabetes

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low risk group

Patients will be stratified based on risk factors significantly contributing to diabetes type 2.

No interventions assigned to this group

Intermediate risk group

No interventions assigned to this group

High risk group

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* No self-reported history of diabetes or pre-diabetes defined as per ADA criteria
* Age greater than 18 years
* Scheduled to receive HbA1c in participating clinic
* Able and willing to give legally effective consent
* Able and willing to participate in patient questionnaires(attached)

Exclusion Criteria

* Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded.
* Baseline HbA1c level above 5.7
* Severe Anemia (defined as Hb less than 8gm/dL)
* Patients with hemoglobinopathies
* Pregnancy
* Polycystic ovarian disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No