372-P: Effect of Whey Protein Consumption on Hypoglycemia Risk in Type 1 Diabetes Patients Fasting during Ramadan—A Randomized Crossover Trial

Many patients with type1 diabetes (T1DM) choose to fast during Ramadan despite the risks involved.

Objective: To examine the effectiveness of whey protein consumption with Suhoor (predawn meal) on the number of hypoglycemic events and time spent in hypoglycemia in T1DM during fasting Ramadan.

Methods: Prospective randomized cross-over design. T1DM planning to fast Ramadan recruited. Data collected using pre/post-Ramadan questionnaires, and FCGM - Freestyle Libre.

Results: 41 T1DM patients were randomized to whey protein consumption with Suhoor for a week then crossed over to Suhoor with no whey protein the second week. 33 were on MDI and 8 CSII. Mean age 24 ±4.2 years (range 18-32), DM duration 14.1 ±7.3 years, 22 (53.7%) female. Pre-Ramadan: A1c 7.6 ±1.07 (5.8-10.3). 19 (46.3 %) reported frequent hypoglycemia (≥3/week), and 3 (7.3 %) reported hypoglycemia unawareness. DaR risk score 9 ±2.4, 5 (12.2%) moderate risk and 36 (87.8%) high risk. During the whey protein vs. no whey protein week mean number of days breaking of fast with main cause being hypoglycemia was 0.73 ±1.1 vs 1.15 ±1.4, p=0.004. No severe, DKA, or hospital admission reported during either regimen. FCGM detected mean hypoglycemia events per patient per week of whey protein vs none regimen was 0.7 vs 1.1, p=0.07; for post-Suhoor (3-6am), and 0.3 vs 0.6, p=0.05 for pre-Iftar (4-6pm). AGP report: GMI 7.5 ±1.5 vs 7.4 ±1.5, p=0.7, Time in target (70-180 mg/dl) 46.4 ±17.3% vs49.4 ±17.3%, p=0.1, Time below target (<70mg/dl) 5.1 ±5.6% vs 5.9 ±5.3%, p=0.2, Time above target (>180mg/dl) 48.5 ±18.6% vs 44.7 ±18.6%, p=0.09, and Glucose variability 39.8 ±8.04% vs 40.8 ±8%, p=0.3. 51.2% of patients thought whey protein consumption with Suhoor was beneficial, and 68.4% would use it in future Ramadan.

Conclusion: Adding whey protein to Suhoor meal reduced the need to break fasting but did not affect TBR or hypoglycemic events. Larger studies needed to study effectiveness of this approach.

ClinicalTrials.gov registered