Recommendation to insulin pump users is to change catheters every 3 days. Convergent data point to inflammation for catheter-related insertion site problems. Objective: to explore if adding a tiny amount of non-steroidal anti-inflammatory drug (NSAID) into insulin solution increases catheter wearing time compare to insulin alone.
Methods: Double-blinded randomized study in insulin pump users with type 1 diabetes. Participants were instructed to keep catheters as long as glycemic control was acceptable and insertion site remained comfortable. Subjects performed 4 experiments: 2 testing lispro and 2 testing the mixed solution (lispro: 90 units/ml + ketorolac: 3 mg/ml), each experimental period separated by a 1-week washout. Safety parameters were measured at entry vs. end of study (including plasma ketorolac concentration). We defined responders as participants wearing catheter ≥ 1 day using lispro+ketorolac vs. lispro.
Results: Fourteen subjects completed the study (males: 7, age: 43.5±18.0 years, diabetes duration: 29.6±13.9 years, pump therapy: 9.0±4.5 years, A1c: 7.1±0.6%). There was no catheter wearing time difference (lispro+ketorolac: 7.45±2.99 vs. lispro: 7.82±2.64 days). The daily doses of insulin and ketorolac were respectively 46.44±12.39 units and 1.55±0.41 mg. Ketorolac plasmatic concentration was at 19.7±17.6 ng/ml (1000 times lower than after clinically indicated doses). From entry vs. end of study, creatinine increased (70±17 vs. 81±19 µmol/L, p=0.018) and glomerular filtration rate declined (119±33 vs. 109±34 ml/min/1.73m2, p=0.028). Wearing time improved in responders (n=7, 50%): 6.04±1.38 vs. 7.97±1.68 days (p=0.018).
Conclusions: While no difference was observed overall, a large sub-group of patients could be responders to the addition of some NSAID to insulin. Due to the small sample size, the true magnitude of kidney function deterioration is unknown and might not be clinically significant.
J. Ardilouze: None. F. Gobeil: None. J. Menard: None. D. Bovan: None. V. Messier: Other Relationship; Self; Eli Lilly and Company. M. Savard: None. J. Baillargeon: 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.