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

Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM: Comparing the Concept of dx/dt With QD Diabetes Prediction Model. D.E.R.M.S Initiative (Doctor Enabled Risk Management System)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01315808

Enrollment

542

Registered

2011-03-15

Start date

2011-03-31

Completion date

2012-09-30

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Brief summary

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Study the rate of change of HbA1c in normal population with known risk factors of diabetes	one year

Secondary

Measure	Time frame	Description
Diabetes prediction model based on the rate of change in HbA1c	one year	To develop a mathematical model which will predict the onset of type 2 dm based on the rate of change in HbA1c valued leading to development of pre-diabetes

Countries

United States

Outcome results