Background: For nonsevere hypoglycemia (NS-H), treatment guidelines recommend 15-20g of rapidly absorbed carbohydrates (CHO) and repeat intake at 15 min until recovery (glucose above 70 mg/dL). The adequacy of this one size fits all approach is questioned. Our group reported an average intake of 32 ± 24g CHO in a type 1 diabetes (T1D) outpatient study. We aim to validate N-SH treatment guidelines in the context of modern therapies.
Methods: Randomized four way cross-over trial to assess treatment with 16g vs. 32 g CHO (glucose tablets) for fasting subcutaneous insulin induced NS-H at two glucose thresholds: a) below 54 mg/dL and b) between 54 to 63 mg/dL. Plasma glucose is measured every 5 min till recovery then at 15-30 min intervals.
Results: Preliminary data was collected for 12 of 33 subjects (53.2 ± 16.8 years old, 58.3% females, HbA1c 56 ± 7.7 mmol/mol, diabetes duration 31.9 ± 15.8 years). Comparison of 16 vs. 32g CHO for each threshold revealed the following change in glucose 15 min post treatment (primary outcome): a) below 54 mg/dL: 12.0 ± 21.8 vs. 17.6± 28.4 mg/dL, p=0.4; b) between 54 to 63 mg/dL: -1.6 ± 19.7 vs. 12 ± 22.7 mg/dL, p=0.06; time needed to recovery (above70 mg/dL): a) below 54 mg/dL: 30 ± 13.6 vs. 29.6 ±14.4 min, p= 0.9; b) between 54 to 63 mg/dL: 37.5 ±14.4 vs. 28.7 ± 17.2 min, p= 0.1 and time needed for disappearance of symptoms: a) below 54 mg/dL: 27.8± 22.3 vs. 22.8 ± 9.5 min, p=0.8; b) between 54 to 63 mg/dL: 24.2 ± 10.7 vs. 16.7± 11.5 min, p=0.5. Regression analysis will be conducted to study response predictors (plasma insulin and catecholamines levels, body composition, etc.)
Conclusion: The response to nonsevere hypoglycemia treatment is extremely variable. A one size fits all recommendation is unlikely to be appropriate. Data of this trial will add to the knowledge of hypoglycemia treatment in T1D.
N. Taleb: None. V. Messier: Other Relationship; Self; Eli Lilly and Company. V. Parent: None. D. Bovan: None. A. Brazeau: None. R. Rabasa-Lhoret: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk A/S.
Canadian Institutes of Health Research (354024); JDRF (4-SRA-2018-651-Q-R)