Real-World Gestational Diabetes Screening: Problems with the Oral Glucose Tolerance Test in Rural and Remote Australia
Abstract
:1. Introduction
2. Materials and Methods
- Fasting plasma glucose ≥ 5.1 mmol/L
- 1-h plasma glucose ≥ 10.0 mmol/L
- 2-h plasma glucose ≥ 8.5 mmol/L
- FLOXRT protocol: FLOX tube (5 mL BD Biosciences, Australia) stored at room temperature. Aliquots collected at 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, and 4 h.
- FLOXICE protocol: FLOX tube (2 mL BD Biosciences, Australia) placed immediately in ice-slurry. Aliquots collected at 0.25 h, 0.5 h, 0.75 h, and 1 h.
- FC Mix protocol: FC Mix tube (3 mL) stored at room temperature. Aliquots collected at 0.25 h, 0.5 h, 0.75 h, 1 h, and 4 h.
- PST protocol: PST (3 mL BD Biosciences, Australia), centrifuged within 5 min of collection at 1300× g for 5 min, and stored at room temperature. Separated plasma fraction remained in the collection tube for the entire experiment.
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Appendix A
Pathology Laboratory | Location | Fasting Duration | Preferred Specimen | Storage/Transport |
---|---|---|---|---|
Abbott Pathology Laboratory | SA Statewide | 10–12 h (max 16 h) | fluoride-oxalate | No recommendation |
ACT Pathology | ACT Territory wide | 8–12 h | fluoride-oxalate | No recommendation |
Alfred Health | VIC Statewide | > 8 h (no max) | fluoride-oxalate | Transport at RT |
Austin Pathology | VIC Statewide | 8–12 h | fluoride-oxalate | No recommendation |
Australian Clinical Labs | WA Statewide | No recommendation | SST or fluoride-oxalate | No recommendation |
Australian Clinical Labs | SA Statewide | 10–14 h | fluoride-oxalate or capillary if difficult bleed | No recommendation |
Australian Clinical Labs | NSW Statewide, VIC Statewide & NT Territory wide | 12–14 h | fluoride-oxalate or capillary if difficult bleed | No recommendation |
Cabrini Health | VIC Metropolitan | 8–12 h | No recommendation | No recommendation |
Capital Pathology | NSW Statewide & ACT territory wide | No recommendation | fluoride-oxalate | No recommendation |
Clinipath | WA Statewide | 10–16 h | fluoride-oxalate | No recommendation |
Dorevitch Pathology | VIC Statewide | 8–10 h | fluoride-oxalate | No recommendation |
Douglass Hanly Moir Pathology | NSW Statewide | 8–12 h | fluoride-oxalate | RT |
Eastern Health Pathology | VIC Metropolitan | Overnight (max 16 h) | fluoride-oxalate | No recommendation |
Goulburn Valley Health | VIC Regional | 10–14 h | fluoride-oxalate | Standard transport recommendation, ASAP 2–24 °C |
Hobart Pathology | TAS Metropolitan | 8–15 h | fluoride-oxalate | No recommendation |
Launceston Pathology | TAS Metropolitan | 8–15 h | fluoride-oxalate | No recommendation |
Laverty Laboratory | NSW & ACT Statewide | 8–14 h | fluoride-oxalate | Do not centrifuge; Refrigerate |
Melbourne Pathology | VIC Statewide | 8–12 h | fluoride-oxalate | No recommendation |
Monash Pathology | VIC Metropolitan | 8–16 h | fluoride-oxalate | No recommendation |
NSW Health Pathology—North | NSW Statewide | 10 h (no min or max) | fluoride-oxalate | No recommendation for storage; transport 2–8 °C |
NSW Health Pathology—SEALS | NSW South East | 8–10 h | fluoride-oxalate/EDTA | Refrigerate |
NSW Health Pathology—SSWPS | NSW Metropolitan | From 10 pm (no specific duration) | Not specified | If delayed separate serum and refrigerate; transport at RT |
Pathology Queensland | QLD Statewide | Overnight (no specific duration) | fluoride-oxalate | No storage recommendation; transport cool |
Pathology South | TAS Metropolitan | 8–16 h | fluoride-oxalate/EDTA | No recommendation |
Pathwest | WA Statewide | 10–16 h | fluoride-oxalate | No recommendation |
QML Pathology | QLD Statewide | 8–16 h | SST or fluoride-oxalate | No recommendation |
Royal Children’s Hospital Laboratory Services | VIC Metropolitan | 10 h (no min or max) | fluoride-oxalate | No recommendation |
SA Pathology | SA Statewide | 10–16 h | fluoride-oxalate | No storage recommendation; transport < 25 °C |
Southern IML | NSW Statewide | 10–12 h | SST | No recommendation |
St Vincent’s Pathology | VIC Metropolitan | 10 h (no min or max) | fluoride-oxalate | No recommendation |
Sullivan Nicolaides Pathology | QLD Statewide | 8–16 h | SST | No recommendation |
Sydpath | NSW Metropolitan | From 10 pm (no specific duration) | fluoride-oxalate | No recommendation |
TML Pathology | TAS Metropolitan | 8–12 h | Not specified | No recommendation |
Western Diagnostic | WA Statewide & NT Territory wide | No recommendation | fluoride-oxalate | No recommendation |
Women’s and Children’s Pathology, The Royal Children’s Hospital | VIC Metropolitan | 10 h | fluoride-oxalate or SST if centrifuged < 3 h if fluoride-oxalate not collected | No recommendation |
OGTT Sample | Timed Aliquot Plasma Glucose (mmol/L) | |||
---|---|---|---|---|
15 min | 30 min | 45 min | 1 h | |
Fasting | 4.9 ± 0.49 ** | 4.9 ± 0.46 * | 4.9 ± 0.47 | 4.9 ± 0.45 |
1-h | 6.5 ± 1.75 * | 6.6 ± 1.85 ** | 6.5 ± 1.76 | 6.4 ± 1.75 |
2-h | 5.8 ± 1.24 | 5.8 ± 1.25 | 5.8 ± 1.26 | 5.8 ± 1.28 |
Beta Coefficients (95% CI) p-Value | ||||
---|---|---|---|---|
Plasma Glucose | Delay | Delay^2 | Constant | |
FLOXICE algorithm | ||||
Fasting PG | 0.999 | 0.108 | −0.004 | 0.125 |
(0.966–1.032) p < 0.001 | (0.093–0.122) p < 0.001 | (−0.004–(−)0.003) p < 0.001 | (−0.034–0.283) p = 0.122 | |
1-h PG | 0.981 | 0.107 | −0.004 | 0.279 |
(0.961–1.000) p < 0.001 | (0.074–0.139) p < 0.001 | (−0.005–(−)0.002) p < 0.001 | (0.140–0.419) p < 0.001 | |
2-h PG | 0.949 | 0.091 | −0.003 | 0.426 |
(0.919–0.979) p < 0.001 | (0.055–0.127) p < 0.001 | (−)0.002) p < 0.001 | (0.243–0.610) p < 0.001 | |
FC mix algorithm | ||||
Fasting PG | 0.986 | 0.106 | −0.004 | 0.386 |
(0.953–1.019) p < 0.001 | (0.091–0.121) p < 0.001 | (−0.004–(−)0.003) p < 0.001 | (0.227–0.545) p < 0.001 | |
1-h PG | 1.043 | 0.112 | −0.004 | 0.146 |
(1.015–1.071) p < 0.001 | (0.066–0.158) p < 0.001 | (−0.006–(−)0.002) p < 0.001 | (−0.055–0.347) p = 0.154 | |
2-h PG | 1.098 | 0.105 | −0.004 | −0.182 |
(1.075–1.120) p < 0.001 | (0.078–0.132) p < 0.001 | (−0.005–(−)0.003) p < 0.001 | (−0.321–(−)0.044) p = 0.01 |
OGTT Sample | OGTT by Standard Procedures | Standard OGTT Adjusted by Song et al. Algorithm | Standard OGTT Adjusted by FC Mix Algorithm | ||||||
---|---|---|---|---|---|---|---|---|---|
Median Delay to Analysis (h) | PG | Cumulative GDM Diagnosis | PG | PG Difference vs. Standard Protocol | Cumulative GDM Diagnosis | PG | PG Difference vs. Standard Protocol | Cumulative GDM Diagnosis | |
Fasting | 4.9 (3.6–6.2) | 4.33 ± 0.44 | 19 (5.2) | 4.82 ± 0.49 | 0.49 ± 0.06 | 93 (25.3) | 5.04 ± 0.43 | 0.71 ± 0.12 | 167 (45.4) |
1-h | 3.8 (2.5–5.1) | 7.03 ± 1.79 | 34 (9.2) | 7.60 ± 1.93 | 0.57 ± 0.15 | 109 (29.6) | 7.80 ± 1.85 | 0.78 ± 0.15 | 179 (48.6) |
2-h | 2.9 (1.5–4.2) | 5.99 ± 1.50 | 43 (11.7) | 6.35 ± 1.59 | 0.37 ± 0.09 | 118 (32.1) | 6.62 ± 1.62 | 0.64 ± 0.20 | 186 (50.5) |
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Characteristic | Total Cohort n (%) | OGTT Complete n = 501 (85.1%) | OGTT not Done or Incomplete n = 88 (14.9%) | p-Value |
---|---|---|---|---|
Maternal characteristics | ||||
Age (years) | 589 (100%) | 28.8 ± 5.7 | 27.1 ± 5.0 | 0.008 |
Ethnicity | < 0.001 | |||
Non-Indigenous | 324 (55.0%) | 300 (92.6%) | 24 (7.4%) | |
Aboriginal and Torres Strait Islander | 229 (38.9%) | 169 (73.8%) | 60 (26.2%) | |
Other high-risk ethnicity † | 36 (6.1%) | 32 (88.9%) | 4 (11.1%) | |
BMI after 24 weeks (kg/m2) | 589 (100%) | 28.5 ± 6.1 | 28.5 ± 7.2 | 0.92 |
BMI category ‡ | 0.28 | |||
Normal or underweight (≤ 28.4) | 330 (56.0%) | 281 (85.2%) | 49 (14.8%) | |
Overweight (28.5–32.9) | 130 (22.1%) | 115 (88.5%) | 15 (11.5%) | |
Obese (≥ 33.0) | 129 (21.9%) | 105 (81.4%) | 24 (18.6%) | |
Parity (prior delivery ≥ 20 weeks) ≥ 1 at enrolment | 401 (68.1%) | 336 (83.8%) | 65 (16.2%) | 0.21 |
Family history of diabetes § | 181 (30.7%) | 146 (80.7%) | 35 (19.3%) | 0.046 |
Any antenatal smoking | 162 (27.5%) | 116 (71.6%) | 46 (28.4%) | < 0.001 |
Antenatal urinary tract infection | 30 (5.1%) | 26 (86.7%) | 4 (13.3%) | 0.80 |
Previous caesarean delivery ¶ | 70 (17.5%) | 62 (88.6%) | 8 (11.4%) | 0.23 |
Length of gestation at first antenatal presentation (weeks) | 589 (100%) | 9.8 ± 5.8 | 11.2 ± 7.1 | 0.057 |
Remoteness classification of health service | 0.220 | |||
MMM2 | 50 (8.5%) | 48 (96.0%) | 2 (4.0%) | |
MMM3 | 383 (65.0%) | 320 (83.6%) | 63 (16.4%) | |
MMM6 | 78 (13.2%) | 72 (92.3%) | 6 (7.7%) | |
MMM7 | 78 (13.2%) | 61 (78.2%) | 17 (21.8%) | |
Newborn characteristics | ||||
Gestational age at delivery (weeks) | 589 (100%) | 39.2 ± 1.5 | 38.8 ± 1.6 | 0.015 |
Birthweight (g) | 589 (100%) | 3458 ± 531 | 3221 ± 513 | < 0.001 |
Length (cm) # | 586 (99.4%) | 50.6 ± 2.7 | 49.3 ± 2.5 | < 0.001 |
Head circumference (cm) †† | 587 (99.7%) | 34.6 ± 1.6 | 34.2 ± 1.5 | 0.025 |
Sex—Male | 303 (51.4%) | 266 (87.8%) | 37 (12.2%) | 0.056 |
OGTT Sample | OGTT by FLOXICE Protocol | OGTT by Standard Procedures | Standard OGTT Adjusted by FLOXICE Algorithm | |||
---|---|---|---|---|---|---|
PG | Delay to Analysis (h) | PG | PG Difference v FLOXICE Protocol | PG | PG Difference v FLOXICE Protocol | |
Fasting | 4.9 ± 0.47 | 3.0 ± 0.4 | 4.5 ± 0.51 *** | −0.42 [−0.47 to −0.37] (−9.9% to −7.5%) | 4.9 ± 0.50 | 0.02 [−0.04 to 0.07] (−0.7% to 1.4%) |
1-h | 6.5 ± 1.76 | 2.0 ± 0.4 | 6.1 ± 1.67 *** | −0.38 [−0.47 to −0.28] (−6.8% to −4.8%) | 6.5 ± 1.64 | −0.01 [−0.12 to 0.10] (−1.1% to 1.8%) |
2-h | 5.8 ± 1.25 | 1.1 ± 0.4 | 5.6 ± 1.12 ** | −0.26 [−0.42 to −0.10] (−7.0% to −1.5%) | 5.8 ± 1.07 | −0.02 [−0.18 to 0.13] (−2.9% to 3.2%) |
OGTT Sample | OGTT by FC Mix Protocol | OGTT by Standard Procedures | Standard OGTT Adjusted by FC Mix Algorithm | |||
---|---|---|---|---|---|---|
PG | Delay to Analysis (h) | PG | PG Difference v FC Mix Protocol | PG | PG Difference vs. FC Mix Protocol | |
Fasting | 5.1 ± 0.47 | 3.0 ± 0.4 | 4.5 ± 0.51*** | −0.62 [−0.67 to −0.56] (−13.6% to −10.9%) | 5.1 ± 0.50 | −0.01 [−0.06 to 0.05] (−1.3% to 1.0%) |
1-h | 6.8 ± 1.88 | 2.0 ± 0.4 | 6.1 ± 1.67*** | −0.63 [−0.84 to −0.43] (−11.3% to −7.1%) | 6.8 ± 1.74 | −0.01 [−0.21 to 0.18] (−2.2% to 2.8%) |
2-h | 6.0 ± 1.28 | 1.1 ± 0.4 | 5.6 ± 1.12** | −0.49 [−0.73 to −0.26] (−10.8% to 4.2%) | 6.0 ± 1.28 | −0.03 [−0.20 to 0.14] (−3.1% to 3.5%) |
Mean Glucose ± SD (mmol/L) | n (%) Above Diagnostic Threshold at Each OGTT Sample | Cumulative n (%) Diagnosed with GDM | |||||||
---|---|---|---|---|---|---|---|---|---|
Aboriginal (n = 169) | Other Ethnicity (n = 332) | p-Value | Aboriginal (n = 169) | Other Ethnicity (n = 332) | p-Value | Aboriginal (n = 169) | Other Ethnicity (n = 332) | p-Value | |
Unadjusted OGTT | |||||||||
Fasting PG | 4.2 ± 0.49 | 4.3 ± 0.40 | 0.005 | 9 (5.3%) | 13 (3.9%) | 0.467 | 9 (5.3%) | 13 (3.9%) | 0.467 |
1-h PG | 7.1 ± 1.74 | 6.9 ± 1.72 | 0.208 | 10 (5.9%) | 18 (5.4%) | 0.819 | 14 (8.3%) | 26 (7.8%) | 0.860 |
2-h PG | 6.1 ± 1.63 | 5.9 ± 1.39 | 0.245 | 13 (7.7%) | 18 (5.4%) | 0.319 | 20 (11.8%) | 34 (10.2%) | 0.587 |
FLOXICE adjusted OGTT † | |||||||||
Fasting PG | 4.7 ± 0.47 | 4.8 ± 0.41 | 0.022 | 30 (17.8%) | 86 (25.9%) | 0.041 | 30 (17.8%) | 86 (25.9%) | 0.041 |
1-h PG | 7.6 ± 1.67 | 7.4 ± 1.69 | 0.114 | 14 (8.3%) | 23 (6.9%) | 0.583 | 33 (19.5%) | 96 (28.9%) | 0.023 |
2-h PG | 6.4 ± 1.52 | 6.2 ± 1.32 | 0.126 | 16 (9.5%) | 25 (7.5%) | 0.454 | 39 (23.1%) | 104 (31.3%) | 0.053 |
FC Mix adjusted OGTT | |||||||||
Fasting PG | 4.9 ± 0.46 | 5.0 ± 0.41 | 0.017 | 49 (29.0%) | 147 (44.3%) | 0.001 | 49 (29.0%) | 147 (44.3%) | 0.001 |
1-h PG | 8.0 ± 1.77 | 7.7 ± 1.80 | 0.110 | 17 (10.1%) | 37 (11.1%) | 0.711 | 54 (32.0%) | 159 (47.9%) | 0.001 |
2-h PG | 6.8 ± 1.76 | 6.5 ± 1.52 | 0.111 | 24 (14.2%) | 32 (9.6%) | 0.125 | 61 (36.1%) | 166 (50.0%) | 0.003 |
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Jamieson, E.L.; Spry, E.P.; Kirke, A.B.; Atkinson, D.N.; Marley, J.V. Real-World Gestational Diabetes Screening: Problems with the Oral Glucose Tolerance Test in Rural and Remote Australia. Int. J. Environ. Res. Public Health 2019, 16, 4488. https://doi.org/10.3390/ijerph16224488
Jamieson EL, Spry EP, Kirke AB, Atkinson DN, Marley JV. Real-World Gestational Diabetes Screening: Problems with the Oral Glucose Tolerance Test in Rural and Remote Australia. International Journal of Environmental Research and Public Health. 2019; 16(22):4488. https://doi.org/10.3390/ijerph16224488
Chicago/Turabian StyleJamieson, Emma L., Erica P. Spry, Andrew B. Kirke, David N. Atkinson, and Julia V. Marley. 2019. "Real-World Gestational Diabetes Screening: Problems with the Oral Glucose Tolerance Test in Rural and Remote Australia" International Journal of Environmental Research and Public Health 16, no. 22: 4488. https://doi.org/10.3390/ijerph16224488
APA StyleJamieson, E. L., Spry, E. P., Kirke, A. B., Atkinson, D. N., & Marley, J. V. (2019). Real-World Gestational Diabetes Screening: Problems with the Oral Glucose Tolerance Test in Rural and Remote Australia. International Journal of Environmental Research and Public Health, 16(22), 4488. https://doi.org/10.3390/ijerph16224488