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

© 2021 by the American Diabetes Association
2021
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.