Table 2.
Prevalence and risk factors for T1DM-related DSPN and painful DSPN in the clinical studies included in the review
| Author/Year | Type of study | No. of T1DM patients | Age mean ± SD (years) | Sex (% of males) | T1DM duration mean ± SD (years) | Criteria for T1DM-related DSPN diagnosis | Criteria for painful T1DM-related DSPN diagnosis | DSPN prevalence in T1DM (%) | Painful DSPN prevalence in T1DM (%) | DSPN risk factors in T1DM | Painful DSPN risk factors in T1DM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Adult patients | |||||||||||
| Adamska et al. (2019) | Interventional, prospective | 148 | 41 (31–49) | 58.7 | 21 (17–30) | Toronto consensus criteria | – | 14 | – | None | – |
| Barbosa et al. (2019) | Cross-sectional, retrospective | 360 | 42 ± 14,4 | 49.4 | 19.2 ± 12.5 | Toronto consensus criteria | DN4 ≥ 4 + LANSS ≥ 12 | 42.8 | 18.9% Of T1DM patients | T1DM duration, hypertension | T1DM duration, hypertension, educational level |
| Falkowski et al. (2019) | Cross-sectional, prospective | 100 | 29 (25–34.5) | 53% | 12.5 (9–16) | ADA criteria | – | 5 | – | – | – |
| Suljic et al. (2019) | Interventional, prospective | 30 | 19.8 ± 3.6 | 31 | 4.9 | NCS abnormalities | – | 23 | – | – | – |
| Andrei et al. (2018) | Interventional, prospective | 126 | > 18 | – | – | ADA criteria | – | 25.4 | – | T1DM duration, hypertension, age, Hba1c, dyslipidemia, retinopathy, nephropathy | – |
| Nancy Cardinez et al. (2018) | Cross-sectional, prospective | 361 | 66 ± 9 | 63 | 53 | MNSI | tingling/pain/ burning/ allodynia in the extremities | 42.7 | 63% of DSPN | - | Female sex |
| Pan et al. (2018) | Cross-sectional, retrospective | 74 | – | – | – | ADA criteria | – | 21.9 | – | T1DM duration, age | – |
| Truini et al. (2018) | Cross-sectional, prospective | 123 | 47.1 (13.8) | 56 | 23.9 ± 11.8 | Toronto consensus criteria | DN4 + clinical examination | 23 | 4.9% | – | |
| Ziegler et al. (2018) | Cross-sectional, prospective | 126 | 59.5 ± 15.4 | 46.8 | – | QST (pressure, temperature, vibration perception) | DSPN with pain and/or burning, | 44.3 | 54.8% of DSPN | – | None |
| Nybo et al. (2017) | Cross-sectional, prospective | 200 | 55.6 | 54.3 | 42 | QST (10 g monofilament) | – | 53 | – | – | – |
| Pop et al. (2016) | Cross-sectional, prospective | 272 | 44.3 ± 11.9 | 61.4% | 22.7 ± 8 | NDS + NSS | – | 79.5 | – | eGDR, retinopathy, T1DM duration | – |
| Wang et al. (2016) | Cross-sectional, prospective | 314 | 32.5 ± 9.7 | 45,8 | 15.2 ± 9.2 | NCS abnormalities | – | 22.9 | – | Hba1c, hypertension, smoking, cardiovascular disease | – |
| Bouhassira et al. (2013) | Cross-sectional, retrospective | 297 | 48,3 ± 16 | 52.2 | 20.8 ± 12.4 | MNSI | DN4 ≥ 4 | – | 14,7% of T1DM patients | – | – |
| Araszkiewicz et al. (2011) | Interventional, prospective | 140 | 28 | 45.7 | 13 (IQR: 8–19) | Clinical abnormalities + QST (vibration and pressure perception) | – | 21.4 | – | – | – |
| Abbott et al. (2011) | Cross-sectional, prospective | 1338 | 37.6 ± 12.9 | 56.1 | 17 (10–26) | NDS, NSS, QST (10 g monofilament) | NSS ≥ 5 and NDS ≥ 3 | 16.2 | 22.7% | – | Age, female sex, ethnicity |
| Van Acker et al. (2009) | Cross-sectional, prospective | 344 | 45.9 ± 15 | 54.2 | 16.5 ± 17 | Neuropen (pain, touch/ pressure perception) | DN4 ≥ 4 | 25.6 | 5.8% of T1DM patients | Age, T1DM duration, dyslipidemia, all other diabetes complications | Age, T1DM duration, nephropathy, obesity, dyslipidemia |
| Beulens et al. (2008) | Cross-sectional, retrospective | 1735 | 39 | 50 | – | Clinical abnormalities + QST (vibration perception) | – | 38 | – | – | – |
| González-Clemente et al. (2005) | Cross-sectional, prospective | 120 | 27.17 ± 6.3 | 54.8 | 18.9 | MNSI | – | 30 | – | – | – |
| Tesfaye et al. (2005) | Longitudinal | 1172 | – | – | – | Clinical abnormalities + QST (vibration perception) | – | 28.5 | – | Hba1c, T1DM duration. hypertension, smoking, obesity, dyslipidemia, cardiovascular disease | – |
| Cantòn et al., (2004) | Cross-sectional, retrospective | 278 | 24.8 ± 6.7 | 56.5 | 10 | San Antonio criteria (NCS, QST, AFT) | – | 4.3 | – | Hba1c, smoking | – |
| Shalitin et al. (2002) | Cross-sectional, retrospective | 217 | 23.4 (7,5–49) | 47 | 13.2 (1–34) | NDS | – | 17 | – | Hba1c, T1DM duration, age | – |
| Chistyakov et al. (2001) | Cross-sectional, prospective | 166 | 25.0 ± 13.4 | 58.4 | 9.6 ± 9.2 | Clinical + NCS abnormalities | – | 49.4 | – | – | – |
| Christen et al. (1999) | Cross-sectional, retrospective | 441 | 31.4 ± 7.4 | 75.2 | 6.5 ± 3.5 | Clinical abnormalities (2 symptoms + 2 signs) | – | 3.2 | – | Hba1c, height, smoking, female sex | – |
| Young et al. (1993) | Cross-sectional, multicentre study | 2426 | 45(18–90) | 53.7 | 13 (0–62) | Standardized questionnaire and clinical examination | – | 22.7 | – | Age, T1DM duration | – |
| Pediatric patients | |||||||||||
| Sherif et al. (2019) | Cross-sectional, prospective | 70 | 11.9 ± 3.7 | 34.3% | 5.5 ± 3.2 | NDS | – | 22.9 | – | – | – |
| Ghaemi et al. (2018) | Cross-sectional, prospective | 50 | 16,7 ± 7 | 46 | 8.38 ± 3.8 | Clinical + NCS abnormalities | DSPN with pain and/or burning | 24 | 25% of DSPN | Hba1c | – |
| Holiner et al. 2017 | Cohort study, prospective | 38 | 12.6 ± 2.4 | 55.3 | 5.6 ± 3.2 | NCS abnormalities | – | 31.6 | – | None | – |
| Türkyilmaz et al. (2017) | Cross-sectional, retrospective | 111 | 11.5 | 53.2 | < 5 (75%) | NCS abnormalities | – | 24.3 | – | T1DM duration, n of ketoacidosis episodes | – |
| El-Samahy et al. (2016) | Interventional, prospective | 100 | 14.3 ± 3.3 | 60 | – | NDS + NCS abnormalities | – | 23 | – | – | – |
| Louraki et al. (2016) | Cross-sectional, prospective | 85 | 13.5 ± 3.4 | 52.9 | 5.5 ± 3.4 | NCS abnormalities | – | 34.1 | – | – | – |
| Hajas et al. (2016) | Cohort study, prospective | 62 | 13,9 ± 5.9 | 55 | 5.6 ± 5.1 | Clinical + NCS abnormalities | – | 24.2 | – | T1DM duration, Hba1c | – |
| Höliner et al. (2013) | Observational, prospective | 39 | 13.8 ± 2.5 | 61.5 | 6.4 ± 3.0 | NDS + NSS + NCS abnormalities | – | 21 | – | – | – |
| Simsek et al. (2013) | Cross-sectional, retrospective | 1032 | 12.5 ± 4.1 | 49.5 | 4.7 ± 3.2 | Clinical examination and/or NCS abnormalities | – | 1.6 | – | T1DM duration, age | – |
| Jaiswal et al. (2013) | Longitudinal study | 329 | 15.7 ± 4.3 | 49 | 6.2 ± 0.9 | MNSI | – | 8.2 | – | Obesity, hypertension, lower HDL [1] | – |
| Ferreira et al. (2005) | Cross-sectional, prospective | 48 | 12.9 ± 3.5 | 58 | 7 ± 2.5 | Dick’s criteria (NCS and clinical examination) | – | 25 | – | – | – |
T1DM type 1 diabetes mellitus, NCS nerve conduction study, QST quantitative sensory testing, AFT autonomic function tests, NDS Neuropathy Disability Score, NSS Neuropathy Symptom Score, DN4 douleur neuropathique en 4 questions questionnaire, LANSS Leeds assessment of neuropathic symptoms and signs, MNSI Michigan Neuropathy Screening Instrument, ADA American diabetes association, eGDR estimated glucose disposal rate (insulin resistance)