MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of AID-URAI versus AID-RAI. We systematically searched PubMed, Scopus, ProQuest, Web of Science, Cochrane Library, Clinicaltrial.gov, and medRxiv for articles up to 30 October 2024. Percent time-in-range (TIR; 3.9-10 mmol/L), time-below-range (TBR; 3.9- and 3.0-mmol/L), and time-above-range (TAR; >10.0- and 13.9-mmol/L) were extracted. This study was registered in the PROSPERO (CRD42024602279).
RESULTS: Sixteen randomized controlled trials (664 participants) were included in this study. AID-URAI were associated with an increased percentage of TIR, but not clinically significant (pooled mean difference {MD} = 1.07% [95% confidence interval {CI}: 0.11 to 2.02]; I2 = 0%; p = 0.029; high certainty). The favourable effect was consistent in AID systems incorporating automated bolus correction, adults, study duration >4 weeks, and FIASP subgroups. AID-URAI has a 0.35% lower percentage of TBR (<3.9 mmol/L) compared with AID-RAI. There were no significant differences in the risk of diabetic ketoacidosis and severe hypoglycemia between the two groups.
CONCLUSIONS: AID-URAI slightly improves the percentage of TIR and has a good safety profile without increasing the risk of diabetic ketoacidosis and severe hypoglycemia.
MATERIALS AND METHODS: We pooled data from 17 observational studies involving 1,699 patients treated with either CSII or non-CSII (including premixed and MDI) regimen. The study outcomes were the frequencies of hypoglycemia, hyperglycemia and/or ketosis. Given the lack of patient-level data, separate analyses for premixed and MDI regimen were not carried out.
RESULTS: The CSII-treated group (n = 203) was older (22.9 ± 6.9 vs 17.8 ± 4.0 years), and had longer diabetes duration (116.7 ± 66.5 vs 74.8 ± 59.2 months) and lower glycated hemoglobin (7.8 ± 1.1% vs 9.1 ± 2.0%) at baseline than the non-CSII-treated group (n = 1,496). The non-CSII-treated group had less non-severe hypoglycemia than the CSII-treated group (22%, 95% CI 13-34 vs 35%, 95% CI 17-55). Of the non-CSII-treated group, 7.1% (95% CI 5.8-8.5) developed severe hypoglycemia, but none from the CSII-treated group did. The non-CSII-treated group was more likely to develop hyperglycemia (12%, 95% CI 3-25 vs 8.8%, 95% CI 0-31) and ketosis (2.5%, 95% CI 1.0-4.6 vs 1.6%, 95% CI 0.1-4.7), and discontinue fasting (55%, 95% CI 34-76 vs 31%, 95% CI 9-60) than the CSII-treated group.
CONCLUSIONS: The CSII regimen had lower rates of severe hypoglycemia and hyperglycemia/ketosis, but a higher rate of non-severe hyperglycemia than premixed/MDI regimens. These suggest that appropriate patient selection with regular, supervised fine-tuning of the basal insulin rate with intensive glucose monitoring might mitigate the residual hypoglycemia risk during Ramadan.
MATERIALS AND METHODS: Seventy-four participants, with type 1 (T1D, n = 24), type 2 (T2D, n = 11), or gestational (n = 39) diabetes, were enrolled across 13 sites (9 in United Kingdom, 4 in Austria). Average gestation was 26.6 ± 6.8 weeks (mean ± standard deviation), age was 30.5 ± 5.1 years, diabetes duration was 13.1 ± 7.3 years for T1D and 3.2 ± 2.5 years for T2D, and 49/74 (66.2%) used insulin to manage their diabetes. Sensors were worn for up to 14 days. Sensor glucose values (masked) were compared with capillary SMBG values (made at least 4 times/day).
RESULTS: Clinical accuracy of sensor results versus SMBG results was demonstrated, with 88.1% and 99.8% of results within Zone A and Zones A and B of the Consensus Error Grid, respectively. Overall mean absolute relative difference was 11.8%. Sensor accuracy was unaffected by the type of diabetes, the stage of pregnancy, whether insulin was used, age or body mass index. User questionnaires indicated high levels of satisfaction with sensor wear, system use, and comparison to SMBG. There were no unanticipated device-related adverse events.
CONCLUSIONS: Good agreement was demonstrated between the FreeStyle Libre System and SMBG. Accuracy of the system was unaffected by patient characteristics, indicating that the system is safe and accurate to use by pregnant women with diabetes.