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Clinical Trials/NCT01315808
NCT01315808
Terminated
Not Applicable

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)

Wyckoff Heights Medical Center1 site in 1 country542 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
Wyckoff Heights Medical Center
Enrollment
542
Locations
1
Primary Endpoint
Study the rate of change of HbA1c in normal population with known risk factors of diabetes
Status
Terminated
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
September 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Study the rate of change of HbA1c in normal population with known risk factors of diabetes

Time Frame: one year

Secondary Outcomes

  • Diabetes prediction model based on the rate of change in HbA1c(one year)

Study Sites (1)

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