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.
METHODS: A retrospective observational study of 60 type 1 and 100 type 2 diabetes subjects. All underwent professional continuous glucose monitoring (CGM) for 3-6 days and recorded self-monitored blood glucose (SMBG). Indices were calculated from both CGM and SMBG. Statistical analyses included regression and area under receiver operator curve (AUC) analyses.
RESULTS: Hypoglycemia frequency (53.3% vs. 24%, P Blood Glucose Index (LBGI)CGM, Glycemic Risk Assessment Diabetes Equation (GRADE)HypoglycemiaCGM, and Hypoglycemia IndexCGM predicted hypoglycemia well. %CVCGM and %CVSMBG consistently remained a robust discriminator of hypoglycemia in type 1 diabetes (AUC 0.88). In type 2 diabetes, a combination of HbA1c and %CVSMBG or LBGISMBG could help discriminate hypoglycemia.
CONCLUSION: Assessment of glycemia should go beyond HbA1c and incorporate measures of GV and glycemic indices. %CVSMBG in type 1 diabetes and LBGISMBG or a combination of HbA1c and %CVSMBG in type 2 diabetes discriminated hypoglycemia well. In defining hypoglycemia risk using GV and glycemic indices, diabetes subtypes and data source (CGM vs. SMBG) must be considered.
METHODS: This prospective, randomized controlled, open-label trial evaluated 50 women with insulin-treated GDM randomized to either retrospective CGM (6-day sensor) at 28, 32 and 36 weeks' gestation (Group 1, CGM, n = 25) or usual antenatal care without CGM (Group 2, control, n = 25). All women performed seven-point capillary blood glucose (CBG) profiles at least 3 days per week and recorded hypoglycaemic events (symptomatic and asymptomatic CBG
METHODOLOGY: This study was conducted in 2 tertiary centres: Hospital Putrajaya (HPJ) and Hospital Universiti Sains Malaysia (HUSM) from February to May 2020. Muslim T1DM patients between ages 8 to18 who intended to fast during Ramadan were given Ramadan-focused education. CGM iPro2® (Medtronic) was used before and during Ramadan, complemented by finger-prick glucose monitoring or self-monitoring of blood glucose (SMBG).
RESULTS: Of the 32 patients, only 24 (12 female) were analysed. Mean age was 13.6 ± 3.1 years old, mean HbAlc was 9.6 ± 1.9% and mean duration of illness was 5.4 ± 3.4 years. Majority (91.7%) were on multiple dose injections (MDI) while only 8.3% were on continuous subcutaneous insulin infusion (CSII). All fasted in Ramadan without acute complications. Retrospective CGM analysis revealed similar results in time in range (TIR), time in hyperglycaemia and time in hypoglycaemia before and during Ramadan, indicating no increased hypoglycaemic or hyperglycaemic events related to fasting. Glycaemic variability before Ramadan as measured by the LBGI, HBGI and MAG, were similar to values during Ramadan.
CONCLUSION: Ramadan fasting among T1DM children and adolescents, by itself, is not associated with short-term glycaemic deterioration. T1DM youths can fast safely in Ramadan with the provision of focused education and regular SMBG.
Methodology: 148 patients on hemodialysis were analysed, 91 patients had end-stage-diabetic-renal disease (DM-ESRD), and 57 patients had end-stage-non-diabetic renal disease (NDM-ESRD). Glycemic patterns and PHH data were obtained from 11-point and 7-point self-monitoring blood glucose (SMBG) profiles on hemodialysis and non-hemodialysis days. PHH and its associated factors were analysed with logistic regression.
Results: Mean blood glucose on hemodialysis days was 9.33 [SD 2.7] mmol/L in DM-ESRD patients compared to 6.07 [SD 0.85] mmol/L in those with NDM-ESRD (p<0.001). PHH occurred in 70% of patients and was more pronounced in DM-ESRD compared to NDM-ESRD patients (72.5% vs 27.5%; OR 4.5). Asymptomatic hypoglycemia was observed in 18% of patients. DM-ESRD, older age, previous IHD, obesity, high HbA1c, elevated highly-sensitive CRP and low albumin were associated with PHH.
Conclusion: DM-ESRD patients experienced significant PHH in our cohort. Other associated factors include older age, previous IHD, obesity, high HbA1c, elevated hs-CRP and low albumin.
DESIGN: Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.
SETTING: Participants were recruited from a tertiary care children's hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.
PARTICIPANTS: Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.
RESULTS: Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.
CONCLUSION: This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.
METHODS: This open-label, parallel-group, 26-week, multicentre, treat-to-target trial, randomly allocated participants (1:1) to two titration arms. The Simple algorithm titrated IDegAsp twice weekly based on a single pre-breakfast self-monitored plasma glucose (SMPG) measurement. The Stepwise algorithm titrated IDegAsp once weekly based on the lowest of three consecutive pre-breakfast SMPG measurements. In both groups, IDegAsp once daily was titrated to pre-breakfast plasma glucose values of 4.0-5.0 mmol/l. Primary endpoint was change from baseline in HbA1c (%) after 26 weeks.
RESULTS: Change in HbA1c at Week 26 was IDegAspSimple -14.6 mmol/mol (-1.3%) (to 52.4 mmol/mol; 6.9%) and IDegAspStepwise -11.9 mmol/mol (-1.1%) (to 54.7 mmol/mol; 7.2%). The estimated between-group treatment difference was -1.97 mmol/mol [95% confidence interval (CI) -4.1, 0.2] (-0.2%, 95% CI -0.4, 0.02), confirming the non-inferiority of IDegAspSimple to IDegAspStepwise (non-inferiority limit of ≤ 0.4%). Mean reduction in fasting plasma glucose and 8-point SMPG profiles were similar between groups. Rates of confirmed hypoglycaemia were lower for IDegAspStepwise [2.1 per patient years of exposure (PYE)] vs. IDegAspSimple (3.3 PYE) (estimated rate ratio IDegAspSimple /IDegAspStepwise 1.8; 95% CI 1.1, 2.9). Nocturnal hypoglycaemia rates were similar between groups. No severe hypoglycaemic events were reported.
CONCLUSIONS: In participants with insulin-naïve Type 2 diabetes mellitus, the IDegAspSimple titration algorithm improved HbA1c levels as effectively as a Stepwise titration algorithm. Hypoglycaemia rates were lower in the Stepwise arm.