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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01315808
• Other study ID #: whmc1
• Status: Terminated
• Phase: N/A
• First received: March 14, 2011
• Last updated: March 18, 2012
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2012
• Source: Wyckoff Heights Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 542
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	Wyckoff Heights Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Wyckoff Heights Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the rate of change of HbA1c in normal population with known risk factors of diabetes		one year	No
Secondary	Diabetes prediction model based on the rate of change in HbA1c	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	one year	No