Switch From U-100 Insulin Analog to U-500 Regular Insulin in Pumps for Type 2 Diabetes

Study Overview
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Brief Summary
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The aim of the study was to perform a 3-year retrospective analysis from a cohort of patients with type 2 diabetes that were treated by a pump device and were uncontrolled despite high U-100 insulin requirements. The study reports outcomes after the switch from U-100 U/ml Rapid-Acting Analog to U-500 U/ml Regular Insulin, both administered by Continuous Subcutaneous Infusion.

Detailed Description
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This study is a retrospective evaluation of a cohort of patients with Type 2 Diabetes from six French centers, who were previously treated by insulin pump therapy, and then switched from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin (Eli Lilly Inc, France) between June 2011 and September 2017. All participants had been previously treated by Multiple Daily Insulin injections and then had been treated by Continuous Subcutaneous Insulin Infusion with U-100 Rapid Acting Insulin analog administered by an insulin pump. Patient's selection criteria included an insulin-resistant state defined by a Total Daily insulin Dose greater than 100 U per day, and a switch from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin during the study period. Data collection from patient medical records included HbA1c, lipid levels, weight, Total Daily insulin Dose, and the recordings of hypoglycemia episodes. Outcomes were recorded at different timelines including baseline and 6, 12, 24 and 36-months after the switch from U-100 to U-500 insulin. Blinded continuous glucose monitoring (CGM) (ipro2, Medtronic Inc., USA) was analyzed in a subgroup of patients having CGM data available at baseline on U-100 insulin and after 6-months on U-500 insulin.

Official Title
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Three-year Retrospective Study on the Switch From Rapid-acting Insulin Analog to Concentrated U-500 Regular Insulin in Insulin-resistant Type 2 Diabetes Patients Treated by Pump Therapy

Conditions
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Type 2 Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T2D diabetes Pump therapy with U-100 U/ml rapid-acting analog prior to initiation of U-500 U/ml insulin Total daily Insulin dose > 100 U per day Exclusion Criteria: follow up < 3 months

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differential HbA1c before and after insulin switch | HbA1c comparison between baseline and 1, 2, 3 year(s) after the switch to U-HbA1c comparison between baseline and 1, 2, 3 year(s) after the switch to U-500 insulin | baseline, 1-year, 2-years, 3-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Daily Insulin Dose | Total Daily Insulin Dose at baseline and 1, 2, 3 year(s) after the switch to U-500 insulin | baseline, 1-year, 2-years, 3-years | 
| Body Weight | Body Weight measured at baseline and 1, 2, 3 year(s) after the switch to U-500 | baseline, 1-year, 2-years, 3-years | 
| Lipids | Plasma Lipids measured at baseline and 1, 2, 3 year(s) after the switch to U-500 | baseline, 1-year, 2-years, 3-years | 
| Hypoglycemia events | Episodes of Hypoglycemia recorded before and during the study | baseline, 1-year, 2-years, 3-years | 
| Continuous Glucose Monitoring before and after insulin switch | Continuous Glucose Monitoring comparison between baseline and 6-month after the switch to U-500 | baseline, 6-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, Insulin Pump, Concentrated Insulin