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New Modalities in Diabetes Diagnosis. Presented By: Kristin J. Brown , MSIV Dr. William M. Scholl College of Podiatric Medicine July 2011. Image source: http://www.nsinc.org/what-we-treat.php. Who Should Be Tested?. According to the ADA 1 : Overweight/obese adults BMI >25

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new modalities in diabetes diagnosis

New Modalities in Diabetes Diagnosis

Presented By:

Kristin J. Brown, MSIV

Dr. William M. Scholl College of Podiatric Medicine

July 2011

Image source: http://www.nsinc.org/what-we-treat.php

who should be tested
Who Should Be Tested?

According to the ADA1:

Overweight/obese adults

BMI >25

Who have one or more additional risk factors

At age 45 years

Repeat testing every 3 yrs

If pre-diabetic, test every year.

methods of diagnosis
Methods of Diagnosis
  • Source: ADA’s “Standards of Medical Care”1
hba1c vs fpg ogtt 1
HbA1c vs. FPG & OGTT1
  • ≥6.5 diagnose DM
  • Disadvantages
    • Higher in cost
    • Limited availability for testing.
    • Can be altered in patients with anemia and hemoglobinopathies.
  • Benefits
    • Fasting not required
    • Greater pre-analytical stability than FPG
    • Less vulnerable to alterations than FPG during stress & illness.
fpg 1
FPG1
  • Studies have shown the FPG test has a specificity exceeding 96%, but it is only 50% sensitive.2
fpg ogtt 1
FPG & OGTT1
  • OGTT has been shown to have a sensitivity of 73% and specificity of 80%.2
  • Both FPG and OGTT are invasive, fasting exams that suffer from poor reproducibility.2
www ngsp org 3
www.ngsp.org3

HbA1c Assay Interferences

“If your diabetes patient has a hemoglobin variant, your lab should use one of the methods that does not show interference from the variant, thus producing an accurate A1C result.”

complications
Complications
  • Diabetes complications1,4:
    • CVD**
    • PVD
    • Nephropathy
    • Retinopathy
    • Neuropathy
      • Peripheral and autonomic
    • Hearing loss
    • Stroke
    • HTN

Image source: http://www.netheryeye.com/OurServices/DiabeticRetinopathy.aspx

neuropathy 1 4
Neuropathy1,4
  • One of the most common late complications of DM.
  • Leading cause of non-traumatic amputations in the US.
  • Has a role in other late complications of diabetes.
    • Neuropathic ulcerations!
  • Increases risk of mortality.
neuropathy etiology
Neuropathy Etiology
  • Excess sugars and proteins broken down by the Maillard reaction5:
    • Creates AGE’s
  • AGE’s (Advanced Glycation End products)5
    • Increased in hyperglycemia & oxidative stress
    • Sugars cross-link with other proteins
    • Contribute to segmental demyelination and interact with nitric oxideneronal apoptosis.

Image source: http://www.artistaday.com/?p=5717/

age s
AGE’s
  • Increased in skin collagen in those with neuropathy.5
    • Especially pentosidine and cross-lines
    • These when excited with near-UV and blue light.

fluoresce

Image source: http://thegist.dermagist.com/how-to-increase-collagen-and-elastin-production

age s1
AGE’s
  • First screened via punch biopsy that often times required a suture for closure.2
  • Now studies using near infrared (NIR) technologies.2
    • Non-invasive
    • Portable & immediate results
    • Readings corrected for intrinsic fluorescence parameters. (dark vs. light skin, etc.)

Image source: http://www.punchbiopsycpt.com/what-is-a-punch-biopsy

studies
Studies
  • M.N. Ediger, B. Olson, and J Maynard. “Noninvasive Optical Screening for Diabetes.” Journal of Diabetes Science & Technology. 2009;3(4):776-780.6
    • Retrospective cohort of 2,793 subjects
    • All identified as naïve & at risk based on the ADA’s Standard of Care Guidelines.
    • Compared FPG, HbA1c, and OGTT to SIF.
      • OGTT at 2hr 75g was considered the baseline.
    • Results
studies1
Studies
  • J.D. Maynard et al. “Noninvasive Type 2 Diabetes Screening”. Diabetes Care. 2007;30(5):1120-1124.7
    • 351 subjects with one or more DM risk factors.
    • Ages 21-86 years
    • Compared HbA1c, FGT, SIF vs. OGTT
    • 84 pts had AGT (OGTT >140 mg/dL)
    • Results
studies2
Studies
  • B.N. Conway et al. “Skin Intrinsic Fluorescence Correlates with Autonomic and Distal Symmetrical Polyneuropathy in Individuals with Type 1 Diabetes.” Diabetes Care. 2011;34:1000-1005.5
    • 111 people with DM1
    • Mean age 49 years
    • Determined if CDSP and autonomic neuropathy associated with SIF vs. HbA1c.
    • Results
scout ds by veralight 8
Scout DS by VeraLight8

Image source: http://www.veralight.com/SCOUT_Video.html

scout ds by veralight 81
Scout DS by VeraLight8

Image source: http://www.veralight.com/SCOUT_Video.html

scout ds by veralight 82
Scout DS by VeraLight8

≥50 =diabetic

<50 =normal

Image source: http://www.veralight.com/SCOUT_Video.html

corneal confocal microscopy
Corneal Confocal Microscopy
  • “A rapid, non-invasive technique that enables a prospective and reiterative evaluation of the human cornea at high magnification [1-2 µm resolution].”9
  • Utilizes confocal optics, which allows examination of a focused point.9
  • Coronal sections of the cornea.
    • Can visualize corneal epithelium, Bowman’s membrane (nerve-complex), stroma, and endothelium.
    • Even better than histopathological exams!9
  • Fun fact: The cornea is the most densely innervated part of the human body!9
corneal confocal microscopy cont
Corneal Confocal Microscopy Cont…
  • The cornea contains C and Aδ fibers.9
    • Reminder: C fibers are large, unmyelinated fibers responsible for slow, aching pain. Aδcause fast, sharp pain.
  • Those fibers account for the majority of symptoms in diabetic neuropathy, and have been shown to be damaged first.9
study
Study
  • M. Tavakoli, et al. “Corneal Confocal Microscopy: A novel noninvasive test to diagnose and stratify the severity of human diabetic neuropathy.” Diabetes Care. 2010;33(8):1792-1797.10
    • 110 DM and 17 healthy pts.
    • Assessed on NDS, QST, NCV (sural & peroneal), NCCA, CCM.
    • Results
slide22

normal

mild

moderate

severe

Image source: M. Tavakoli, et al. “Corneal Confocal Microscopy: A novel noninvasive test to diagnose and stratify the severity of human diabetic neuropathy.” Diabetes Care. 2010;33(8):1792-1797.O5

conclusion
Conclusion
  • Skin Intrinsic Fluorescence and Corneal Confocal Microscopy are two technologies at the forefront of diabetic and diabetic neuropathy diagnosis.
  • They are non-invasive techniques that give immediate results, and have been shown by multiple studies to be superior to other techniques.
  • While they aren’t seen widely now, you will probably see them soon…
thank you questions
Thank you.Questions?

Image source: http://www.nsinc.org/what-we-treat.php

references

References

American Diabetes Association. “Standards of Medical Care in Diabetes-2010.” Diabetes Care. 2010:33(supplement 1):511-561.

Hull, E., et al. “Noninvasive, optical detection of diabetes: model studies with porcine skin.” Optics Express. 2004;12(19):4496-4509.

Centers for Disease Control & Prevention. “Harmonizing Hemoglobin A1C Testing.” Accessed online July 12th, 2011. http://www.ngsp.org/bground.asp

American Diabetes Association website. “Living with Diabetes: Complications.” Accessed online July 10, 2011. http://www.diabetes.org/living-with-diabetes/complications/

Conway, B.N. et al. “Skin Intrinsic Fluorescence Correlates with Autonomic and Distal Symmetrical Polyneuropathy in Individuals with Type 1 Diabetes.” Diabetes Care. 2011;34:1000-1005.

Ediger, M.N., B. Olson, and J Maynard. “Noninvasive Optical Screening for Diabetes.” Journal of Diabetes Science & Technology. 2009;3(4):776-780.

Maynard, J.D. et al. “Noninvasive Type 2 Diabetes Screening”. Diabetes Care. 2007;30(5):1120-1124.

VeraLight Website. “The VeraLight Scout DS.” Accessed online July 10th, 2011. http://www.veralight.com/products.html

Hossain, P., A. Sachdev, and R. Malik. “Early detection of diabetic peripheral neuropathy with corneal confocal microscopy.” The Lancet. 2005;366:1340-1342.

Tavakoli, M. et al. “Corneal Confocal Microscopy: A novel and noninvasive test to diagnose and stratify the severity of human diabetic neuropathy.” Diabetes Care. 2010;33(8):1792-1797.

Malik, R.A. et al. “Corneal Confocal Microscopy: a non-invasive surrogate of nerve fibre damage and repair in diabetic patients.” Diabetologia. 2003;46:683-688.