Managing Impending Non-Severe Hypoglycemia with Oral Carbohydrates in Type 1 Diabetes: The REVERSIBLE Trial.

Objective Current guidelines recommend initiating the treatment of non-severe (NS) hypoglycemia with 15g of carbohydrates (CHO) at 15-minute intervals when blood glucose (BG) reaches <70 mg/dL (3.9 mmol/L). Despite this recommendation, NS hypoglycemia management remains challenging for people living with type 1 diabetes (pwT1D). We aim to assess the efficacy of 15g of CHO at higher BG levels. Research Design and Methods A total of 29 pwT1D participated in an open-label cross-over study. Following inpatient subcutaneous insulin-induced decrease in BG in the fasting state, 16g of oral CHO was administered at a plasma glucose (PG) of <70 mg/dL (3.9 mmol/L), ≤80 mg/dL (4.5 mmol/L) or ≤90 mg/dL (5.0 mmol/L). The primary outcome was the time spent in hypoglycemia (<70mg/dL) after the initial CHO intake. Results When comparing <70 mg/dL (control) to ≤80 mg/dL and ≤90 mg/dL treatment groups, 100% vs. 86% (p=0.1201) vs. 34% (p<0.0001) of participants reached hypoglycemia. These hypoglycemic events lasted 26.0±12.6 vs. 17.9±14.7 (p=0.026) vs. 7.1±11.8 (p=0.002) minutes, with a PG nadir of 56.57±9.91 mg/dL vs. 63.60±7.93 mg/dL (p=0.008) vs. 73.51±9.37 mg/dL (p=0.002) respectively. In the control group, 69% of participants required more than one treatment to reach or maintain normoglycemia (≥70 mg/dL) compared to 52% in the ≤80 mg/dL group and 31% in the ≤90 mg/dL group with no significant rebound hyperglycemia (>180 mg/dL) within the first hour. Conclusion For some impending NS hypoglycemia episodes, pwTID could benefit from CHO intake at a higher BG level.