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. 2024 Mar 18;15(5):929–1045. doi: 10.1007/s13300-024-01541-6

Table 3.

Clinical outcomes in women with gestational diabetes mellitus

First author_Year Treatment arms Sample size Time points FBG (mean ± SD) mg/dl or mmol/l PPG (mean ± SD) mg/dl or mmol/l 1-h PPG (mean ± SD) mg/dl or mmol/l 2-h PPG (mean ± SD) mg/dl or mmol/l
RCT
Wasim_2019 [21] Insulin-Humulin R and NPH 141 Baseline 120 ± 22.4 NR NR NR
Delivery 96.6 ± 6.2 NR NR NR
Metformin 137 Baseline 117 ± 18.1; p = 0.215 vs. insulin NR NR NR
Delivery 92.1 ± 6.0; p = 0.001 vs. insulin NR NR NR
Galal_2019 [20] Human insulin 50 NA 92.42 ± 4.93 129.82 ± 7.88 NR NR
Metformin 56 NA;1 week 86.88 ± 5.02; p = 0.0001 117.30 ± 8.84; p = 0.0001 NR NR
Eid_2018 [34] Insulin (NPH + regular insulin) 116 Before treatment 116.83 ± 24.5 NR NR 171.1 ± 41.8
After treatment 84.1 ± 3.1 NR NR 101.4 ± 4.8
Metformin 113 Before treatment 114.38 ± 19.87; p = 0.64 insulin vs. metformin NR NR 168.9 ± 39.1; p = 0.79 insulin vs. metformin
After treatment 81.7 ± 3.6, p = 0.065 insulin vs. metformin NR NR 95.9 ± 4.7, p = 0.53 insulin vs. metformin
Huhtala_2018 [43] NPH insulin and/or rapid-acting insulin lispro or insulin aspart 107 At enrolment 5.57 ± 0.42 NR 11.2 ± 1.24 7.91 ± 1.75
Metformin 110 At enrolment 5.52 ± 0.55; p = 0.44 vs. insulin NR 11.2 ± 1.49; p = 0.61 vs. insulin 8.33 ± 1.76; p = 0.076 vs. insulin
Diet 103 At enrolment 5.38 ± 0.43 NR 10.9 ± 1.06 7.81 ± 1.91
Ghomian_2018 [33] Levemir (insulin detemir) + aspart 143 At treatment onset 92.21 ± 4.41 NR NR 152.58 ± 4.87
Delivery 88.03 ± 5.00 NR NR 118.99 ± 6.24
Metformin 143 At treatment onset 91.22 ± 4.37; p = 0.57 vs. insulin NR NR 152.25 ± 5.11; p = 0.69 vs. insulin
Delivery 89.16 ± 3.44; p = 0.79 vs. insulin NR NR 119.38 ± 4.03; p = 0.33 vs. insulin
Khan_2017 [24] Insulin (mixed human suspension) 385 Before treatment 122.37 ± 9.94 NR NR 174.46 ± 6.02
After treatment 76.88 ± 7.75 NR NR 112.34 ± 5.02
Metformin 385 Before treatment 130.06 ± 10.34; t = 10.53; p = 0.000 vs. insulin NR NR 175.18 ± 7.89; t = 1.42; p = 0.157 vs. insulin
After treatment 82.28 ± 5.51; t = 11.15; p = 0.000 vs. insulin NR NR 111.94 ± 7.02; t = − 0.909; p = 0.364 vs. insulin
Zawiejska_2016 [23] Basal-bolus insulin (human recombined insulin) 43 At booking 5.5 ± 0.7 NR NR NR
At term 4.7 ± 1; p < 0.0001 change from baseline NR NR NR
Metformin and metformin + insulin 35 At booking 5.8 ± 0.6 NR NR NR
At term 5.2 ± 0.5; p = 0.004 change from baseline; p (booking) = 0.101; p (at term) = 0.008 vs. insulin NR NR NR
Behrashi_2016 [67] Regular insulin and NPH 129 NA 83.75 ± 6.77 NR NR 107.14 ± 7.99
Glibenclamide 120 NA 84.85 ± 5.26; p = 0.38 vs. insulin NR NR 114.38 ± 81.74; p = 0.95 vs. insulin
Ashoush_2016 [22] Insulin-control (regular + NPH) 48 Baseline 106.4 ± 4.4 NR 208.3 ± 13.2 177.6 ± 8.8
1 week 93.5 ± 2.6 NR NR 122.9 ± 7.2
First 2 weeks 103.5 ± 3.5 NR NR 170.5 ± 8.2
Last week 79.9 ± 3.7 NR NR 111.3 ± 4.2
Last 2 weeks 80.8 ± 4.7 NR NR 112.2 ± 6.8
Metformin and metformin + insulin-research 36 + 11 Baseline 105.7 ± 4.7, p = 0.417 vs. insulin NR 203.9 ± 9.9, p = 0.075 vs. insulin 175.7 ± 10.0, p = 0.318 vs. insulin
1 week 92.8 ± 2.8, p = 0.257 vs. insulin NR NR 120.6 ± 7.8, p = 0.142 vs. insulin
First 2 weeks 100.7 ± 3.3; p = 0.014 vs. insulin NR NR 166.9 ± 8.9, p = 0.197 vs. insulin
Last week 78 ± 3.1; p = 0.0008 vs. insulin NR NR 109.9 ± 3.7; p = 0.104 vs. insulin
Last 2 weeks 78.9 ± 3.5; p = 0.029 vs. insulin NR NR 111 ± 5.2; p = 0.342 vs. insulin
Somani_2016 [26] Regular/NPH or both 33 Baseline 102.67 ± 9.61 NR 216.61 ± 22.39 179.0 ± 20.98
Delivery 82.27 ± 5.57 NR NR 113.06 ± 11.71
Metformin 32 Baseline 100.03 ± 10.79; p = 0.30 vs. insulin NR 215.22 ± 15.34; p = 0.77 vs. insulin 182.69 ± 17.33; p = 0.44 vs. insulin
Delivery 85.41 ± 5.96; p = 0.32 vs. insulin NR NR 121.28 ± 11.0; p = 0.005 vs. insulin
Mirzamoradi_2015 [42] Insulin (regular + NPH) 59 At diagnosis 112.15 ± 19.39 NR NR NR
At treatment to delivery 123.42 ± 14.71 120.15 ± 9.56 NR NR
Glyburide 37 At diagnosis 109.83 ± 68.99; p = 0.72 vs. glyburide NR NR NR
At treatment to delivery 114.02 ± 10.65; p = 0.83 vs. glyburide 115.46 ± 8.21; p = 0.83 vs. glyburide NR NR
Ainuddin_2015 [36] Insulin (short- + intermediate-acting)-GDM 75 Treatment initiation 172 ± 21.5 NR NR NR
Throughout pregnancy 97.4 ± 2.5 NR NR NR
Metformin-GDM 43 Treatment initiation 138 ± 16 NR NR NR
Throughout pregnancy 96.4 ± 5.7 NR NR NR
Insulin + metformin-GDM 32 Treatment initiation 144 ± 23 NR NR NR
Throughout pregnancy 95.3 ± 6.3 NR NR NR
Arshad_2014 [25] Regular and NPH 25 1 week of enrolment 117 ± 29.0 NR NR NR
Diet + exercise 25 1 week of enrolment 90.96 ± 16.84; p = 0.00 vs. insulin NR NR NR
Mukhopadhyay_2014 [58] Insulin 30 At enrolment 109.3 ± 19.63 194.3 ± 18.47 NR NR
Before confinement 88.17 ± 8.44 128 ± 12.38 NR NR
Glibenclamide 30 At enrolment 103 ± 14.62; p = 0.199 vs. insulin 184.1 ± 20.46; p = 0.048 vs. insulin NR NR
Before confinement 88.23 ± 6.55; p = 0.97 vs. insulin 122.7 ± 10.3; p = 0.07 vs. insulin NR NR
Mesdaghinia_2012 [56] NPH and regular 100 Baseline NR NR NR NR
Delivery NR NR NR NR
Metformin 100 Baseline NR NR NR NR
Spaulonci_2013 [68] NPH insulin 46 Before treatment 100.87 ± 15.05 Breakfast: 119.81 ± 21.59; lunch: 123.72 ± 19.4; dinner: 132.63 ± 23.82 NR NR
After treatment 88.35 ± 7.45 Breakfast: 106.45 ± 11.75; lunch: 111.43 ± 8.84; dinner: 119.09 ± 16.47 NR NR
Metformin 46 Before treatment 102.15 ± 21.96 Breakfast: 120.67 ± 24.03; lunch: 120.61 ± 22.63; dinner: 131.22 ± 25.43 NR NR
After treatment 90.09 ± 16.29 Breakfast: 107.7 ± 16.69; lunch: 106.87 ± 11.16; dinner: 110.76 ± 11.57; p = 0.020 NR NR
Tertti_2013 [38] Insulin (NPH + lispro + aspart) 107 At randomisation NR NR NR NR
Metformin (23 required additional insulin) 110 At randomisation NR NR NR NR
Delivery NR NR NR NR
Niromanesh_2012 [39] NPH and regular as needed 80 First 2 weeks after randomisation 91.2 ± 7.9 114.6 ± 12.1 NR NR
Second week after randomisation and until delivery 86.2 ± 8.7 107.6 ± 10.0 NR NR
Randomisation-delivery 88.7 ± 6.3 111.1 ± 9.0 NR NR
Metformin 80 First 2 weeks after randomisation 90.3 ± 9.8; p = 0.529 112.2 ± 13.0; p = 0.237 NR NR
Second week after randomisation and until delivery 86.2 ± 8.6; p = 0.985 110.4 ± 11.9; p = 0.106 NR NR
80 Randomisation-delivery 88.3 ± 7.7; p = 0.683 111.3 ± 9.1; p = 0.870 NR NR
Balaji_2012 [69] BIAsp 30 163 At enrolment 103.77 ± 17.94 NR NR 164.66 ± 38.71
Delivery 92.97 ± 14.44 NR NR 127.59 ± 28.99
BHI 30 157 At enrolment 108.24 ± 24.88 NR NR 163.83 ± 48.12
Delivery 95.43 ± 18.96 NR NR 126.98 ± 29.89
Hassan_2012 [40] Regular and intermediate-acting human insulin 75 At enrolment Median (range): 102.11 (89–110) NR NR Median (range): 236.41 (180–309)
Third trimester/delivery NR NR NR NR
Metformin 75 At enrolment Median (range): 100.89 (88–120); p = 0.079 vs. insulin NR NR Median (range): 231.56 (188–280); p = 0.058 vs. insulin
Third trimester/delivery NR NR NR NR
Ijas_2011 [41] Long-(Protaphane) and rapid-(humalog) acting insulin 50 At randomisation 5.4 ± 0.6 mmol NR NR 8.1 ± 1.8
Metformin 47 At randomisation 5.6 ± 0.9 mmol NR NR 8.2 ± 1.9
Observational
Han_2020 [72] Insulin lispro + metformin 62 Before treatment 8 NR NR Breakfast: 13; lunch: 11.8; dinner: 11.8
After treatment 5.2 NR NR Breakfast: 7; lunch: 6; dinner: 6
Insulin lispro 55 Before treatment 7.9 NR NR Breakfast: 12.8; lunch: 11.8; dinner: 11.8
After treatment 7; p < 0.05 vs. insulin + metformin NR NR Breakfast: 9.2, lunch: 8.8, dinner: 9; p < 0.05 vs. insulin + metformin
Krishnakumar_2020 [73] Insulin 37 Baseline 103.81 ± 7.98 128.30 ± 7.26 NR NR
2 months 94.59 ± 5.77; p < 0.0001 vs. baseline 116.05 ± 6.01; p < 0.0001 vs. baseline NR NR
Metformin 44 Baseline 105.16 ± 15.16 130.23 ± 16.83 NR NR
2 months 94.84 ± 6.18; p < 0.0001 vs. baseline 117.86 ± 6.54; p < 0.0001 vs. baseline NR NR
Rodrigues 2020 [50] Insulin 41 3rd trimester NR NR NR NR
Metformin + insulin 94 3rd trimester NR NR NR NR
Metformin only (subgroup of metformin +) 77 3rd trimester NR NR NR NR
Zaharieva_2020 [75] Insulin vs. no insulin Total-90; insulin n = 34 NR 5.2 vs. 4.8; p = 0.0004 NR NR NR
Tang_2019 [31] Insulin 180 NA Median (IQR): 5.8 (5.5, 6.2) NR Median (IQR): 10.2 (9.0, 11.8) Median (IQR): 8.6 (7.5, 9.3)
MNT 354 NA Median (IQR): 5.3 (5.1, 5.5); p < 0.001 NR Median (IQR): 9.5 (8.3, 10.6); p < 0.001 Median (IQR): 8.3 (7.0, 9.4); p < 0.292
McGrath_2018 [82] Insulin (NPH or Levemir and/or NovoRapid) 83 At diagnosis 4.8 NR NR NR
Metformin 83 At diagnosis 4.9 NR NR NR
Diet + lifestyle 83 At diagnosis 4.4; p < 0.001 across treatment arms NR NR NR
Rowan_2018 [85] Insulin (Adelaide cohort) 51 At enrolment 88 ± 13 NR NR NR
Metformin (Adelaide cohort) 51 36 weeks NR NR NR NR
Insulin (Auckland cohort) 58 At enrolment 88 ± 16 NR NR NR
Metformin (Auckland cohort) 58 36 weeks NR NR NR NR
Insulin (Adelaide cohort) 54 At enrolment 90 ± 11 NR NR NR
Metformin (Adelaide cohort) 54 36 weeks NR NR NR NR
Insulin (Auckland cohort) 45 At enrolment 95 ± 16 NR NR NR
36 weeks NR NR NR NR
Simeonova-Krstevska_2018 [28] Levemir (detemir) + aspart 101 NA 5.8 ± 1.4; p < 0.05 vs. metformin 7.9 ± 1.9; p < 0.05 vs. metformin NR NR
Metformin 48 NA 5.3 ± 0.7; p = NS vs. diet 7.0 ± 1.2; p = NS vs. diet NR NR
Diet 200 NA 5.1 ± 0.9; p < 0.01 vs. insulin 6.9 ± 1.6; p < 0.05 vs. insulin NR NR
Olmos_2017 [89] Basal-bolus insulin therapy (BBIT) 73 NA NR NR NR NR
Without BBIT (diet/metformin) 58 NA NR NR NR NR
Xie_2017 [90] Research arm (insulin aspart intensive treatment/insulin pump) 45 NA 5.2 ± 0.6 NR NR 7.3 ± 1.2
Reference arm (insulin aspart + detemir) 45 NA 6.8 ± 0.6; p < 0.05 vs. research arm NR NR 8.8 ± 1.2; p < 0.05 vs. research arm
Ito_2016 [92] RHI or rapid-acting insulin (insulin aspart or lispro) and NPH insulin) 32 At diagnosis 91.5 ± 7.9 NR 179.9 ± 34.9 150.5 ± 28.5
32 Delivery 93.2 ± 9.4 NR 162.2 ± 41.2 124.2 ± 31.4
Diet 70 At diagnosis 89.6 ± 8.7; p = 0.313 vs. insulin NR 155.3 ± 33.6; p = 0.001 vs. insulin 135.3 ± 29.7; p = 0.017 vs. insulin
Delivery 90.8 ± 7.7; p = 0.251 vs. insulin NR 142.9 ± 40.7; p = 0.064 vs. insulin 118.0 ± 29.0; p = 0.410 vs. insulin
Koren_2016 [55] Insulin detemir 29 NA 5.1 ± 0.5 NR 8 ± 1.3 7.78 ± 1.3
Glyburide 62 NA 5.1 ± 1; p = 0.91 NR 7.8 ± 1.3; p = 0.82 7.12 ± 1.8; p = 0.13
Ozgu-Erdinc_2016 [29] Insulin 144 NA Median (range): 87 (56–275) NR Median (max–min): 144 (67–340) Median (max–min): 132 (53–320)
Diet 115 NA Median (range): 80 (58–157); p < 0.001 NR Median (max–min): 137.5 (72–212); p = 0.002 Median (max–min): 118.5 (72–207); p < 0.001
Yanagisawa_2016 [30] Insulin 36 NA OGTT: 88 ± 11 meal TT: 92 ± 16 NR OGTT: 177 ± 29; meal TT: 147 ± 32 OGTT: 161 ± 22; Meal TT: 128 ± 32
MNT 77 NA OGTT: 83 ± 9; p = 0.013 vs. insulin, meal TT: 84 ± 7; p = 0.014 NR OGTT: 173 ± 28; p = NS vs. insulin Meal TT: 121 ± 20 p < 0.001 OGTT: 157 ± 25; p = NS vs. insulin meal TT: 104 ± 18 p < 0.001
You_2016 [99] Regular insulin (NPH if required) 55 Baseline 96.9 ± 15.4 NR 200.7 ± 33.9 195.9 ± 37.2
Fast-acting insulin analogues (NPH if required)-aspart or lispro 142 Baseline 99.4 ± 20.5; p = 0.494 NR 208.0 ± 36.4; p = 0.194 188.8 ± 40.6; p = 0.249
Benhalima_2015 [32] Short-acting or long-acting insulin or both 145 NA 97.6 ± 18.8 NR 194.7 ± 30.1 185.2 ± 28.5
Diet 456 NA 87.7 ± 10.3; p < 0.0001 vs. insulin NR 184.5 ± 25.8; p < 0.0001 vs. insulin 175.0 ± 22.8; p < 0.0001 vs. insulin
Deepaklal_2014 [100] Insulin lispro 201 At enrolment/first trimester 99.01 Post breakfast: 126.9 ± 44.2, post lunch: 125.5 ± 38.3, post dinner: 127.2 ± 38.6 NR NR
Delivery NR Post breakfast: 106.5 ± 18.8, post lunch: 111 ± 18.4, post dinner: 111.8 ± 19.5 NR NR
Marques_2014 [102] NPH insulin 33 NA NR NR NR NR
Metformin 32 NA NR NR NR NR
Goh_2011 [109] Intermediate-acting isophane insulin and short-acting insulin analog 399 NA 5.4 ± 1.1 NR NR 9.9 ± 2.1
Metformin 465 NA 5.3 ± 0.8 NR NR 9.4 ± 1.6
Diet 371 NA 4.5 ± 0.7, p < 0.0001 across treatment arms NR NR 9.5 ± 1.1, p = 0.0008 across treatment arms
Flores-Le Roux_2010 [111] Insulin 41 3rd trimester NR NR NR NR
Diet 70 3rd trimester NR NR NR NR
NEF-GDM 18 3rd trimester NR NR NR NR

BBIT basal-bolus insulin therapy, BHI biphasic premixed human insulin, BIAsp biphasic insulin aspart, FBG fasting blood glucose, GDM gestational diabetes mellitus, NA not applicable, NEF no endocrinologic follow-up, NPH neutral protamine Hagedorn, NR not reported, PPG postprandial glucose, RCT randomized controlled trial, RHI regular human insulin, SD standard deviation