Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with Type 2 Diabetes, treated by pump therapy with U-100 U/ml rapid-acting analog, with a Total daily Insulin dose > 100 U per day, willing to switch to U-500 U/ml insulin administered by Pump
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |