Boston Diabetes Research Institute · April 2026
A first-line mass-screening test for diabetic microvascular disease. Adds sentinel nerve markers to HbA1c, runs the composite through a proprietary evidence-based algorithm, and returns a risk-stratified result in under two minutes.
NIMS Pilot · Sensitivity comparison
Specificity
0%
High-value referrals only
Youden Index
0
Near-perfect discrimination
PPV
0%
Referrals that warrant it
NPV
0%
Confident clear results
Source: NIMS Neurology Pilot Report v1.5, April 2026. 120-patient cohort, a 2500-bed tertiary care and teaching hospital, Hyderabad.
Three names. One system.
Three names appear throughout this site. They describe three different things that work together as a system. Clearing up the distinction makes everything that follows read cleanly.
The Test
What the patient receives
The screening test itself. A composite of DPNCheck sural nerve values and HbA1c, interpreted through BDRS. Extends HbA1c screening beyond glycaemia into direct measurement of nerve status.
Point of care. Two minutes. One tier.
The Algorithm
What powers the result
Boston Diabetes Risk Score. An evidence-based proprietary algorithm developed through internal research and multi-country prospective studies, refined through supervised analytical learning as each new test is performed.
Proprietary. Evidence-based. Continuously refined.
The Device
What captures the signal
FDA-cleared Class II point-of-care device. Measures bilateral sural nerve amplitude and conduction velocity in under two minutes. Runs in a routine office visit. No radiology or neurophysiology lab required.
Point of care. Routine office visit.
Three discoveries. One screening program.
For years, the team at the Boston Diabetes Research Institute has been asking a hard question: why do so many patients develop devastating complications even when their diabetes appears well controlled? That work led to three connected discoveries that form the scientific foundation of BeyondA1C.
A1C reflects average glucose but says nothing about the oxidative stress, nerve injury, or vascular damage that may already be underway in a patient's tissues.
BDRI's research establishes that nerve dysfunction tends to appear first. Peripheral neuropathy is an independent predictor of microvascular complications, including retinopathy, nephropathy, and cardiovascular autonomic neuropathy, in diabetic patients (Vinik AI et al. Endocrinol Metab Clin North Am. 2004;33(2):405-415).
A point-of-care screening program using DPNCheck (FDA-cleared for sural nerve conduction measurement) and BDRI's proprietary algorithm to generate a composite risk profile across neuropathy, retinopathy, and nephropathy.
50%
of people with diabetes develop peripheral neuropathy, the first sign of microvascular disease
50%
of those cases are completely asymptomatic until advanced stages of damage
3x
more asymptomatic cases detected by nerve conduction studies vs. monofilament testing (Perkins BA et al. Diabetes Care. 2001)
The gap
HbA1c is a good test for what it was designed to measure. It was never built to tell you whether the nerves are still intact. That gap is where BeyondA1C lives.
What HbA1c does
Tells you how much glucose has been in circulation over the past three months. Useful for diagnosis and for tracking glycaemic control over time.
What it does not do
Tell you whether the nerves have already been damaged. Whether axonal density has fallen. Whether a patient with a normal A1c is carrying silent neuropathy.
What BeyondA1C adds
Sural nerve amplitude and conduction velocity at the bedside. Combined with HbA1c, interpreted through BDRS, returned as one tiered clinical action.
Why it matters
BeyondA1C does not replace HbA1c. It works alongside it. HbA1c describes the glucose. BeyondA1C describes what the glucose has done.
Pop-Busui R et al. ADA Position Statement. Diabetes Care 2017;40:136-154. | ADA Standards of Care 2026. | Selvarajah D et al. Lancet Diabetes Endocrinol 2019;7:938-948.
A1C limitations
BDRI's first key finding was documenting the specific ways A1C fails as a standalone measure of diabetic complication risk.
Up to 50% of patients with diabetic neuropathy are completely asymptomatic in the early and moderate stages. Nerve damage accumulates for years with no signal in a standard blood panel. By the time symptoms appear, the window for meaningful intervention has often closed.
Damage begins years before any clinical sign
Glycemic control alone does not fully capture risk for diabetic foot complications. Even patients with A1C levels considered well-controlled remain vulnerable to ulceration and amputation due to neuropathy, microvascular disease, and cumulative glycemic exposure. (J Diabetes Complications. 2020;34(10):107638.)
A1C reflects glycated hemoglobin. It does not measure nerve conduction, retinal vascular integrity, or kidney filtration. Relying on A1C alone leaves the most important window for early intervention completely dark.
Annual US cost of DPN and its complications: $10.9 billion (Gordois A et al. Diabetes Care. 2003;26(6):1790-1795)
How it is performed
Any staff member can run the test. The device finds the right stimulation level on its own. Results are available before the patient leaves the room.
Seat the patient comfortably and expose the ankle. Clean the skin to ensure good sensor contact. Any staff member can do this part.
Under 60 seconds setup
Attach the single-use biosensor and apply a small amount of conductive gel. One biosensor per patient keeps things hygienic and signal quality consistent.
Single-use per patient
Place the device on the ankle and press start. It finds the right stimulation level on its own, then averages 8 to 12 nerve responses to build a reliable, reproducible result.
Fully automated
Enter patient and sural nerve data into the BeyondA1C portal. A color-coded report is instantly downloadable. Upload the PDF to your EHR or share it directly with the patient.
Results in under one minute
54%
Asymptomatic neuropathy detection rate via nerve conduction study vs. 17% for monofilament testing (Perkins BA et al. Diabetes Care. 2001)
95%
Sensitivity vs. reference standard nerve conduction studies (Perkins BA et al. Diabetes Care. 2006)
0.88
Area under the curve for diagnostic accuracy in diabetic polyneuropathy (Hirayasu et al. J Diabetes Investig. 2018)
Why neuropathy
Screening the nerves is not just screening for DPN. Nerve damage is the earliest and most measurable signal of microvascular injury, sharing a common pathogenic axis with nephropathy, retinopathy, and peripheral arterial disease.
The sentinel
Hyperglycaemia, oxidative stress, and capillary injury follow a shared biology across microvascular beds. Peripheral nerve is the most accessible window into that process. A positive BeyondA1C is a trigger for the rest of the microvascular workup.
One two-minute screen. Four microvascular complications triaged.
Diabetic peripheral neuropathy
Directly measured
~50%
of people with diabetes develop peripheral neuropathy over time. BeyondA1C flags axonal loss and conduction slowing before symptoms appear, finding asymptomatic cases roughly 3x more often than monofilament testing.
Pop-Busui 2017; Perkins 2001
Diabetic nephropathy
Accelerated renal decline
Decline in kidney function in diabetes is not uniformly accompanied by albuminuria. BeyondA1C-measured peripheral neuropathy provides an additional marker of systemic microvascular injury that may help identify patients at risk for kidney function decline, including those not flagged by albuminuria alone.
KDIGO 2022; Selvarajah JAMA Netw Open 2020
Diabetic retinopathy
Vision-threatening progression
Peripheral neuropathy is associated with both the presence and increasing severity of diabetic retinopathy, reflecting shared microvascular pathology. Population studies show retinopathy is significantly more common in patients with peripheral neuropathy.
Feldman EL et al. Lancet DE 2019; Ponirakis G et al. BMJ ODRC 2020
Peripheral arterial disease
Large-vessel ischaemia
Nerve and large-vessel ischaemia coexist. A positive screen triggers pedal pulse exam and ABI. Neuropathy severity tracks with retinopathy severity, with markedly higher neuropathy prevalence in advanced vascular stages.
ADA Standards of Care 2026
The evidence
A 120-patient cohort at NIMS, a renowned 2500-bed tertiary care and teaching hospital. A test of BeyondA1C against real patient data in a routine outpatient setting.
0%
Sensitivity: BeyondA1C
0%
Sensitivity: HbA1c alone
0%
Specificity
0
Youden Index
Source: BeyondA1C NIMS Neurology Pilot Report v1.5, April 2026 (120-patient cohort, NIMS Hyderabad). Reference standard: bilateral sural NCS (DPNCheck). HbA1c positive threshold: 6.5% or above.
0
percentage points
more neuropathy patients correctly identified by BeyondA1C than by HbA1c alone
97.8%
Specificity
98.2%
PPV
95.7%
NPV
0.94
Youden Index
2M+ represents cumulative commercial deployment of the DPNCheck device (NeuroMetrix). Sensitivity 95% and AUC 0.88: Perkins BA et al. Diabetes Care 2006; Hirayasu et al. J Diabetes Investig 2018.
How they differ
A1C measures average glucose; BeyondA1C measures sural nerve function. The two tests address different physiological domains. BeyondA1C does not replace A1C.
| Capability | A1C Alone | BeyondA1C |
|---|---|---|
| Detects early nerve damage | No | Yes |
| Associated with retinopathy risk in BDRI studies | No | Yes (research) |
| Asymptomatic case detection | Limited | 3x more |
| Associated with nephropathy progression in BDRI studies | No | Yes (research) |
| Mortality association (DPNCheck + SUDOSCAN; Sloan et al. 2023) | No | Yes (research) |
| Point-of-care, no referral needed | No | Yes |
| Detects neuropathy risk across A1C levels, including below 7% | No | Yes (research) |
The output
BDRS returns a single risk tier for every patient. Every tier carries an action. The clinician does not need to interpret raw electrophysiology. The nurse at a rural clinic and the neurologist at a quaternary hospital work from the same framework.
Positive screen = Tier 2 or above. Every tier carries a specified clinical action.
What it looks like in practice
From the NIMS cohort. Each case describes a clinical situation HbA1c-based screening would not have caught.
49-year-old man
Glycaemia entirely normal. HbA1c-based screening would miss him entirely. The NCV slowing is the only signal, and BeyondA1C catches it.
Normal A1c. BeyondA1C caught it.
41-year-old man
HbA1c just below 7.5%. A1c alone would have led to glycaemic review and stopped there. Both NCS parameters abnormal. Firmly in Tier 3.
Borderline A1c. Active DSPN.
53-year-old man
Referred for vertigo. The neuropathy was incidental. All three parameters significantly abnormal. Needs metabolic control and neuropathy management.
Advanced, multi-domain failure.
Source: BeyondA1C NIMS Neurology Pilot Report v1.0, April 2026. S.No = sequential enrolment number.
"BeyondA1C changes the calculus of the annual diabetes visit. Nerve conduction at the bedside, interpreted and tiered, in two minutes. This is what population-level neuropathy screening looks like."
NIMS Neurology Team, Hyderabad
Nizam's Institute of Medical Sciences · 120-patient pilot site · March-April 2026
Deployment
Because BeyondA1C is a first-line screen with a tiered output, it fits anywhere HbA1c is offered today.
Primary Health Centre
Most diabetic patients first present here. No point-of-care NCS exists at this level today. BeyondA1C fills the gap.
Missing a Tier 3 patient here means months without specialist assessment.
District & Secondary Hospital
Diabetologist usually available. Formal neurophysiology not. BeyondA1C gives a tier on the day of the visit. Tier 3 and above goes upstream.
97.8% specificity means the patients being referred genuinely warrant it.
Tertiary & Quaternary Hospital
Patients arrive without a standardised severity score. BeyondA1C gives a reproducible baseline, the same result whether run by a registrar or a senior resident.
Longitudinal BeyondA1C data validates the intervention thresholds each tier carries.
Diagnostic Laboratory
BeyondA1C sits alongside routine HbA1c testing within a single visit. The score is available before the clinician reviews the lab report.
Solves the problem of HbA1c not being available on the day of point-of-care screening.
The economic case
Diabetic peripheral neuropathy affects up to 50% of people with diabetes, costs the healthcare system over $10 billion annually in downstream complications, and remains vastly underdiagnosed at the primary care level.
38 M
Americans living with diabetes
$10 B+
Annual US cost of DPN-related complications
2 min
Per BeyondA1C screen at the point of care
The cost of late detection
Tier 2
Glycaemic review. Monitoring. Manageable at the primary care level.
Tier 4
Urgent specialist input. Intensive foot surveillance. Hospitalization risk rising.
Tier 5
Real amputation risk. Inpatient care, rehabilitation, prosthetics, and loss of livelihood.
Lower-extremity amputation costs the US healthcare system over $50,000 per episode. Screening that catches patients at Tier 2 instead of Tier 4 is not just better medicine. It is substantially cheaper.
CDC National Diabetes Statistics Report 2024. | Driver VR et al. J Diabetes Sci Technol 2010. | Pop-Busui R et al. Diabetes Care 2017;40:136-154.
Three international corridors
Beyond the United States, BDRI has active programs in three corridors where diabetes is diagnosed late, neuropathy goes untreated, and a point-of-care screen changes the clinical calculus at the system level.
India
101 M
People with diabetes
30 M+
Estimated with DPN
#1
Global burden
India carries the largest absolute diabetes population in the world. Most patients with neuropathy have never had a nerve conduction study. BeyondA1C costs a fraction of a formal NCS and takes two minutes.
BDRI active program: NIMS Neurology, Hyderabad. Clinical pilot complete. Boston Diabetes Hyderabad Centre operational since June 2026.
Anjana RM et al. ICMR-INDIAB-17. Lancet Diabetes Endocrinol 2023;11(7):474-489.
Oman
15.7%
Adult prevalence
Top 20
Global ranking
MOH
Active engagement
Oman has one of the highest diabetes prevalence rates in the Gulf region and a government-funded healthcare system with active interest in NCD screening at the primary care level.
BDRI active program: Ministry of Health engagement underway. Sultan Qaboos Hospital, Salalah, is the anchor site.
IDF Diabetes Atlas 11th edition 2025.
Rest of World
589 M
Global adults
252 M
Undiagnosed
1 in 8
By 2050
The neuropathy screening gap is a global problem. Low- and middle-income countries carry the majority of cases and have the least access to neurophysiology infrastructure.
Additional corridors: Bangladesh, Saudi Arabia, Canada (Alberta multi-centre pilot: 134 screenings, 71.3% positive screen rate).
IDF Diabetes Atlas 11th edition 2025.
The global picture
The IDF Diabetes Atlas 11th edition places the 2024 global diabetes population at 589 million adults. Over four in ten remain undiagnosed. Microvascular complications follow almost always and are the main driver of long-term cost and disability.
589 M
Adults aged 20-79 with diabetes in 2024
1 in 9
Adults worldwide. Rising to 1 in 8 by 2050.
252 M
People living with diabetes, undiagnosed today
Complications are the real burden
USD 1T
Global diabetes-related health expenditure in 2024. A 338% increase in 17 years.
3.4 M
Diabetes-related deaths in 2024. One every nine seconds.
>90%
Of cases are type 2 diabetes. Largely preventable and largely missed until complications appear.
Genitsaridi I et al. IDF Diabetes Atlas 11th edition 2025. Lancet Diabetes Endocrinol 2026;14(2):149-156.
Positioning
BeyondA1C decides who needs to travel the diagnostic path and who does not. Tier 3 and above still require full NCS, specialist review, and formal microvascular workup.
Not this
This
Adjunct to HbA1c. Complement, not a replacement. That is the design.
For patients
No preparation needed. Results in under one minute. Your doctor can order this at any routine diabetes visit.
BDRI's research establishes peripheral neuropathy as an independent predictor of microvascular complications in diabetic patients, including retinopathy, nephropathy, and cardiovascular autonomic neuropathy.
BeyondA1C uses BDRI's proprietary algorithm to process sural nerve conduction data from DPNCheck (FDA-cleared) and generate a composite risk profile. Algorithm updates are subject to regulatory review.
One brief, automated test generates a composite risk profile associated with neuropathy, retinopathy, and nephropathy outcomes, all from a single in-office visit.
Results in under one minute, color-coded by severity. No large equipment, no specialist training. Any primary care, endocrinology, or podiatry clinic can start offering this today.
Clinicians, health systems, and research partners welcome.
Boston Diabetes Research Institute
Request a demonstration, discuss a clinical partnership, or learn how BeyondA1C fits into your care pathway.
Regulatory Notice
DPNCheck is FDA-cleared for the measurement of sural nerve conduction velocity and sensory nerve action potential amplitude (FDA Class II, 21 CFR 882.1850). BeyondA1C is a screening program developed by the Boston Diabetes Research Institute, a division of MedicaMetrix, Inc. The BeyondA1C composite risk profile is generated using DPNCheck and BDRI's proprietary algorithm and is based on BDRI clinical research. BeyondA1C does not constitute a separate FDA-cleared diagnostic test for diabetic retinopathy, nephropathy, or cardiovascular autonomic neuropathy. Associations between DPNCheck-measured sural nerve function and microvascular complication risk reflect published research findings and should not be interpreted as cleared indications for use.
BeyondA1C is intended for use by or under the direction of a licensed healthcare provider. Results should be interpreted in the context of the patient's full clinical picture. This website does not constitute medical advice.
Document Reference: FTP-BDRI-2026-04-12-E | Version: v8 | Effective Date: [PENDING SIGN-OFF] | Sign-offs required: RA / Medical / Legal