A1c Discordance in Diabetes Patients

Not Applicable

Suspended

• Conditions: Diabetes Mellitus
• Interventions: Other: Fast Glycator; Other: Control

• Registration Number: NCT01213277
• Lead Sponsor: Endocrine Research Society

Brief Summary

HbA1c is used as a gold standard to see whether patients have optimal glycemic control. Today, many physicians rely solely on HbA1c to change medication. However, there is a select group of patients that have low average glucose levels but high HbA1c levels. The investigators believe that these patients are fast glycators meaning that they incorporate sugar into their hemoglobin faster than normal. The investigators want to determine whether these patients are fast glycators.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study Start: 2010-10
• Study First Posted: 2010-10-01
• Primary Completion: 2011-05
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patient with diabetes
• Patients who test their sugar levels at least 3 times daily
• Recorded diary of sugar levels for the past month
• Willingness to have blood drawn
• Willingness to allow their blood sugar diary to be photocopied
• Estimated average glucose as derived from A1c is ≥ 4 mmol from measured glucose from self-monitoring blood glucose testing

Exclusion Criteria

• Patient with medical conditions that may affect their study participation or results will be excluded.
• Patients who are anemic
• Renal insufficient with a serum creatinine level > 200 μmol/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fast Glycator	Fast Glycator	The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
Control	Control	These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients

Primary Outcome Measures

Name	Time	Method
Primary endpoint is to see whether they are fast glycators	One Week

Secondary Outcome Measures

Name	Time	Method
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours	One Week