A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.

Study Overview
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Brief Summary
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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.

Official Title
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Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: LINjeta U-100 Insulin
* Drug: Humalog U-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:1)Type 1 diabetes for at least 1 year 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 protocol. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Humalog U-100 Insulin<br> | Drug: Humalog U-100<br>* Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors<br>* Other names: Lispro U-100 insulin;|
| Experimental: LINjeta U-100<br> | Drug: LINjeta U-100 Insulin<br>* LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors<br>* Other names: VIAject U-100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal. |  | 2 weeks | 
| The primary endpoint for this second phase is the 3 hour area under the curve from baseline following a standardized breakfast meal in the outpatient setting. |  | 2 weeks | 
| The primary endpoint for this third phase is daytime (6 am to midnight) average glucose values.is percent of CGMS glucose values in range (70-180 mg/dL) for the third week fo sensor data in each group. |  | 6 weeks |