Huffman DM, McLean GW, Seagrove MA
Continuous Subcutaneous Pramlintide Infusion (CSPI) Therapy in Patients with Type 1 Diabetes: Observations from a Pilot Study. [JOURNAL ARTICLE]
Endocr Pract 2009 Jun 22.:1-20.
Objective: Pramlintide acetate reduces postprandial blood glucose excursions, HbA1c and body weight. We investigated the efficacy and safety of continuous (basal-bolus) subcutaneous (SC) pramlintide infusion (CSPI) in patients with T1DM.Research Design and methods: A 16-wk, open-label, single-arm pilot study enrolled patients (n=11, mean +/-SD; age 39.9+/-4.0 y, A1c 8.20+/-0.60%, wt 92.3+/-18.4 kg, BMI 29.7+/-5.1 kg/m2) with long-term T1DM (20.7+/-1.3 y, duration of pump therapy 9.5+/-6.0 y). Pramlintide basal infusion was begun via continuous SC infusion (Animas(R) 2020 insulin pump) at 9 mug/hr (1.5 U/hr). Premeal boluses were initiated after 3 days at 15 mug and titrated to 60 mug per meal. Basal and bolus insulin doses were reduced 10% upon initiation of CSPI, and adjusted thereafter as needed to prevent hypoglycemia.
Results: After 16 wks pramlintide therapy, mean +/- SD HbA1c decreased to 7.85+/-0.74% (-0.35%). Fasting glucose fell from 198.2+/-66.9 to 135.8+/-63.9 mg/dl. Weight declined to 91.8+/-20.1 kg (-0.5 kg). Mean insulin: CHO ratio decreased 20%; basal insulin was unchanged (27.7 +/- 11.7 U). All subjects experienced mild postprandial hypoglycemia, but no severe hypoglycemia was reported. Three of eleven subjects experienced mild initial nausea, but all subjects successfully titrated bolus doses to 60mug within three weeks.
Conclusions: In this small pilot study in subjects with T1DM using insulin pumps, CSPI seemed safe and well tolerated, did not alter pramlintide pharmacokinetic parameters, and reduced fasting glucose levels. Larger studies of this method for pramlintide administration seem warranted.
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