Abstract
IDF-DaR guidelines recommend change of basal insulin timing to early evening. Randomized trials examining timing of basal insulin during fasting are lacking.
Objective: To compare glucose profiles in T1DM patients taking Glargine at early evening (6-7 pm) versus bedtime (10-12 night) during fasting Ramadan.
Methods: Multicenter open label randomized controlled trial. Patients recruited in 4 centers from 4 cities in Saudi Arabia. Data collected using pre- and post-Ramadan questioners. Glucose data collected via self-monitoring (Roche AccuCheck glucometer/the Abbott Freestyle Libre), and Envision iPro CGM.
Results: 185 T1DM patients randomized; 91 to glargine at 6-7pm (early), and 94 at 10-12 night (late). 32.4% ≤18 years, 53% female, and average duration of DM 11 ±11. No significant differences between the two groups in demographics or DM complications. Early vs. late group: Pre Ramadan A1c 9 ±2.7 vs. 8.75 ±2.1, p=0.35, post Ramadan A1c 8.4 ±2.9 vs. 8.7 ±2.7, p=0.5. Breaking of fast reported in 66 (75.9%) vs. 71 (76.3%), p=0.94; average number of days 4±6 vs. 4±4, p=0.5, and due to hypoglycemia in >90% of cases for both groups. Hypoglycemia most common in Morning 32 (59.3%) vs. 38 (60.35%), p=0.85. Severe hypoglycemia reported in 2 vs. 5 patients, and 1 DKA admission in each group. Combined CGM data during Ramadan: A1c 7.6 ±1.7 vs. 7.7 ±2.1, p=0.63. Average Time in range of 70-180 mg/dl 44.6% vs. 46.1%, p=0.7, Time below range (<70mg/dl) 7.9% vs. 6.4%, p=0.35, and Time above range (>180mg/dl) 47.5 vs. 47.5%, p=0.99. Total hypoglycemic episodes detected by SMBG 4 ±6 vs. 3 ±8, p=0.3, and Low excursions detected by iPro CGM 5 ±6 vs. 4 ±5.5, p=0.22, with AUC below limit 0.5 ±1 vs. 0.15 ±0.85, p=0.03.
Conclusion: Changing glargine timing during Ramadan to early evening hours carries no significant advantage over keeping at bedtime in regards to hypoglycemia and overall glucose profiles.
ClinicalTrials.gov: NCT04383990.
Disclosure
R. Alamoudi: None. M. Hassanein: None. G. S. Khogeer: None. A. Al qarni: None. Y. M. Saleh: Advisory Panel; Self; American Association of Clinical Endocrinologists, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Research Support; Self; Servier Laboratories, Speaker’s Bureau; Self; Abbott Diabetes, Amgen Inc., Ascensia Diabetes Care, Lilly Diabetes, Sanofi-Aventis. A. Aljawhrji: None. M. R. Alsubaiee: None. H. A. Zarif: Advisory Panel; Self; Pfizer Foundation, Speaker’s Bureau; Self; Medtronic. S. B. Alaidarous: Other Relationship; Self; AstraZeneca, Novo Nordisk. S. A. Khashwayn: None.
Funding
King Abdullah International Research Center