Mitigation of hypoglycemia during Ramadan using the flash glucose monitoring system following dose adjustment of insulin and sulphonylurea in patients taking multiple glucose-lowering therapies (The PROFAST-IT Study).

BACKGROUND AND HYPOTHESIS: Patients with type-2 diabetes mellitus (T2DM) on multiple glucose-lowering therapies who fast during Ramadan are at increased risk of hypoglycemia. We have assessed the utility of the flash glucose monitoring system after adjusting the dose of insulin and sulphonylureas to mitigate the risk of hypoglycemia in patients with T2DM who fast during Ramadan. PATIENTS AND METHODS: Patients with T2DM on either basal insulin or a sulphonylurea and at least 2 other glucose-lowering agents received structured education and adjustment of insulin or sulphonylurea dose according to the PROFAST Ramadan protocol. Glucose variability and episodes of hypoglycemia were assessed using the flash glucose monitoring system (Free Style Libre) before and during Ramadan. RESULTS: A total of 33 patients with T2DM (on sulphonylurea (SU+) (n = 21), on basal insulin (BI+) (n = 12) aged 50.8 ± 1.6 years with a diabetes duration of 13.1 ± 6.5 years were studied. The average sensor glucose was 154 ± 34 mg/dl (8.5 ± 1.88 mmol/l) with 65.2% in the target range before Ramadan and the average sensor glucose was 156 ± 36 mg/dl (8.6 ± 2.0 mmol/l) with 67.1% in the target range during Ramadan. The incidence of hypoglycemia in the whole group (2.9 v 2.9) and in the SU+ (3.7 vs 3.0) and BI+ (1.7 vs 2.9) groups and eHbA1c (P = 0.56, P = 0.93), average glucose (P = 0.56, P = 0.92) and time within range (P = 0.63, P = 0.73) did not change in the SU+ and BI+ groups, respectively, before and during Ramadan. CONCLUSION: Structured education with adjustment of the dose of glucose lowering medication alongside use of the FGMS can effectively mitigate the increased risk of hypoglycemia in patients with T2DM on multiple glucose-lowering therapies who fast during Ramadan.

Differential effects of gender and patient background diversity on the changes in metabolic and biophysical profiles in people with type-2 diabetes from different ethnicities who fast during Ramadan (H1439); a prospective study from Qatar.

OBJECTIVE: The 'PROspective Study of dose adjustment of multiple anti-diabetic therapy for Type-2 diabetic patients FASTing the Month of Ramadan aimed to assess the biophysical and metabolic effects of fasting during Ramadan, including HbA1c, weight, blood pressure and lipid profile. STUDY DESIGN METHODS: We performed a prospective study of people with Type-2 diabetes who were on ≥3 drugs for lowering glucose before and after Ramadan of H1438 (May-June 2017) in Hamad Medical Corporation, Qatar. We enrolled 228 participants, of whom 181 completed the study and were included in the analysis. RESULTS: There were 115 (63.5%) men and 66 (36.5%) women, mean age 53.6 ±â€¯9.7 years and mean diabetes duration of 10 ±â€¯6 years. Both HBA1c [7.8% (62 mmol/mol) vs. 7.6% (60 mmol/mol); p = 0.004]; and diastolic BP (75.7 ±â€¯8.55 vs. 68.8 ±â€¯23.1 mmHg, P = 0.001) improved significantly after Ramadan while there was an increase in total cholesterol (3.94 ±â€¯0.89 mmol/l vs 4.11 ±â€¯1.02 mmol/l; p = 0.008) and triglycerides (1.55 ±â€¯0.72 mmol/l vs 1.71 ±â€¯0.9 mmol/l; p = 0.012). Subgroup analysis showed that patients on sulphonylurea, South Asians and males had a significant reduction in both HBA1c and weight. CONCLUSION: Patients with Type 2 diabetes who fast during Ramadan show an improvement in glycaemic control and diastolic blood pressure, but a worsening of total cholesterol and triglycerides, particularly those of South Asian origin and men.

Outcomes of type 1 diabetes mellitus in pregnancy; effect of excessive gestational weight gain and hyperglycaemia on fetal growth.

AIMS: To study pregnancy outcomes in patients with type 1 diabetes mellitus (T1DM) and the factors associated with poor outcomes. METHODS: A retrospective study of 110 patients with T2DM who attended our diabetes in pregnancy clinic at the Women's Wellness and Research centre, Doha, between March 2015 and December 2016 and 1419 normoglycaemic controls. RESULTS: There was no difference in age, weight, and BMI between the two groups. The incidence of macrosomia, shoulder dystocia and stillbirth were similar in the two groups while that of pre-term labour, pre-eclampsia, Caesarean section (CS), large for gestational age (LGA), neonatal ICU (NICU) admission and neonatal hypoglycaemia were significantly higher in the T1DM than in the control group. From a multivariate regression analysis, excessive gestational weight gain was associated with increased risk of LGA (OR 4.53; 95% CI [1.42-14.25]). Last trimester HBA1c was associated with increased risk for macrosomia [OR 2.46, 95% CI [1.03-5.86)]; LGA [ OR 3.25, 95% CI [1.65-6.40)]; increased risk for C-section (OR 1.96, 95% CI [1.12-3.45]), and increased risk of NICU admission (OR 2.46, 95% CI [1.04-5.86]). The changes in HBA1C between the first and last trimester HBA1c was associated with a reduction in the risk of LGA [OR 0.46, 95% CI [(0.28-0.75)] CONCLUSION: T1DM in pregnancy is associated with adverse pregnancy outcomes compared to the general population. Reducing gestational weight gain and improving glycaemic control might improve pregnancy outcomes.

Type 2 diabetes mellitus in pregnancy: The impact of maternal weight and early glycaemic control on outcomes.

OBJECTIVES: To study the pregnancy outcomes in women with type 2 diabetes mellitus (T2DM) and to relate these to maternal risk factors. METHODS: We conducted a retrospective study of 419 women with T2DM (index group)- who attended our diabetes in pregnancy clinic at the Hamad Women's Hospital, Doha, between March 2015 and December 2016 -and 1419 normoglycaemic women (control group). RESULTS: Compared with the controls, T2DM women were older (mean age 34.7 ± 6.9 vs 29.6 ± 5.5 years; p < 0.001) and had a higher BMI (34.5 ± 6.7 vs 28.8 ± 6.1 kg/m2; p < 0.001). The incidence of macrosomia, shoulder dystocia and stillbirth were similar in the two groups, while that of pre-term labour, pre-eclampsia, caesarean section (CS), large for gestational age (LGA), neonatal ICU (NICU) admission, and neonatal hypoglycaemia were significantly higher in the T2DM compared to the control group (p < 0.05). Multivariate regression analysis showed that first trimester HbA1C was associated with an increased risk of LGA (OR 1.17; 95% CI [1.01-1.36]), pre-eclampsia (OR 1.26; 95% CI [1.02-1.54]), neonatal hypoglycaemia (OR 1.32; 95% CI 1.10-1.60) and NICU admission (OR 1.32; 95% CI 1.10-1.60). Pre-pregnancy BMI was associated with increased risk of LGA (OR 1.04; 95%CI [1.00-1.08]), macrosomia (OR 1.06; 95%CI [1.00-1.12]) and CS (OR 1.05; 95% CI [1.01-1.09]). Last trimester HbA1c was associated with an increased risk of LGA [OR 1.53, 95% CI [1.13-2.10)] and CS (OR 1.37, 95% CI [1.01-1.87]). CONCLUSION: T2DM is associated with adverse pregnancy outcomes compared to the normal control in Qatar. Maternal obesity and glycaemic control before and during pregnancy are the main determinants of pregnancy outcomes in women with T2DM.

A pilot study using flash continuous glucose monitoring in patients with type-2 diabetes on multiple anti-diabetic agents during Ramadan.

BACKGROUND: This study aims to examine the incidence of hypoglycaemia, based on activity, during Ramadan in patients with type 2 diabetes mellitus who were on were on three or more anti-diabetic medications. METHODS: Type 2 diabetes patients who fasted during Ramadan and were on three or more anti-diabetic medications were studied for two weeks using flash glucose monitoring. The patients were asked to document all episodes of hypoglycaemia and were classified as active or sedentary according to their daytime activity. RESULTS: The study included 16 patients of whom 10 were active and 6 were sedentary. There were 13 males and 3 females; mean age was 53.4 ±â€¯6.4 years; mean diabetes duration was 15 ±â€¯5.9 years, and mean HbA1C was 7.9 ±â€¯1.3%. Over the two weeks; there were 7.9 episodes of hypoglycaemia recorded per patient; 50% of which were asymptomatic. There was no difference at baseline in age, BMI, HBA1C, diabetes duration, and anti-diabetic medications between the active and sedentary groups. The active group had better glucose control; median blood glucose was (7.1 (5.1-8.5) vs 10.6 (9.6-11.5) mmol p < 0.01), mean estimated HBA1C was (6.2 ±â€¯1.2% vs 8.3 ±â€¯1.0%; p = 0.047). The active group had more episodes of hypoglycaemia compared to the sedentary group (11.6 vs 1.8 hypo episode per patient/two weeks; p = 0.019); most of which were asymptomatic. CONCLUSION: Patients with type 2 diabetes mellitus who are on three or more anti-diabetic medications should be warned about the increased risk of asymptomatic hypoglycaemia during Ramadan. Anti-diabetic medication adjustments during Ramadan should take into account the degree of activity. Flash glucose monitoring system can help patients to fast safely during Ramadan and detect asymptomatic hypoglycaemia.

Incidence of hypoglycaemia in patients with type-2 diabetes taking multiple glucose lowering therapies during Ramadan: the PROFAST Ramadan Study.

OBJECTIVE: To assess the incidence of hypoglycemia in people with type-2 diabetes mellitus (T2DM) on three or more anti-diabetic medications during Ramadan. STUDY DESIGN METHODS: We have studied people with T2DM on three or more glucose-lowering drugs during Ramadan of H1438 (May-June 2017). The dose of each drug was adjusted according to a pre-specified protocol. The incidence of symptomatic or blood glucose confirmed hypoglycemia was recorded during the study. RESULTS: We enrolled 228 people with T2DM; 181 completed the study, and data on hypoglycaemia was available in 172 subjects. There were 115 males and 66 females, (mean age ± SD) 53.6 ± 9.7 years, diabetes duration 10 ± 6 yrs. The incidence of hypoglycaemia was 16.3% (28/172). Univariable logistic regression analysis showed that the risk of hypoglycaemia was increased in Arab subjects compared to Qatari; in those with longer duration of diabetes; and in those on four or more anti-diabetic medications compared to those on three anti-diabetic medications. CONCLUSION: Despite the tailored advice, there is a high incidence of hypoglycemia in people with T2DM taking multiple glucose lowering therapies whilst fasting during Ramadan. Guidelines should address the increased complexity in anti-diabetic medications in patients who fast during Ramadan. Healthcare providers should individualize the modifications in anti-diabetic medications during Ramadan.