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A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.
Trial ID: NCT01067118
The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal.
Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia
Inclusion Criteria:1)Type 1 diabetes for at least 1 year
1. The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide
level and antibody determinations are not needed.
2) Age : 18 years old ¨C 49.99 years old 3) Continuous subcutaneous insulin infusion
(CSII) therapy for at least 3 months 4) Participant consent demonstrated by signing
IRB approved documents 6) HgA1c ¡Ü 9% 7) If participant is female with reproductive
potential, willing to avoid pregnancy and pregnancy test negative. Exclusion
Criteria:1) Chronic oral steroid use
2) The presence of a significant medical disorder that in the judgment of the
investigator will affect the wearing of sensors or the completion of any aspect of the
3) Known clinical history of celiac disease or inflammatory bowel disease. 4)
Participants will have a negative anti-endomysial antibody or anti-tissue
transglutaminase antibody within one year of enrollment.
5) Cystic Fibrosis 6) Inpatient psychiatric treatment in the past 6 months. 7)
Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
8) Clinical diagnosis of gastroparesis. 9) Insulin binding capacity greater than 10
microunits per litter
drug: LINjeta U-100 Insulin
drug: Humalog U-100
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