Switch From U-100 Insulin Analog to U-500 Regular Insulin in Pumps for Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT04371497
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- follow up < 3 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method differential HbA1c before and after insulin switch baseline, 1-year, 2-years, 3-years 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
- Secondary Outcome Measures
Name Time Method Continuous Glucose Monitoring before and after insulin switch baseline, 6-month Continuous Glucose Monitoring comparison between baseline and 6-month after the switch to U-500
Lipids baseline, 1-year, 2-years, 3-years Plasma Lipids measured at baseline and 1, 2, 3 year(s) after the switch to U-500
Hypoglycemia events baseline, 1-year, 2-years, 3-years Episodes of Hypoglycemia recorded before and during the study
Total Daily Insulin Dose baseline, 1-year, 2-years, 3-years Total Daily Insulin Dose at baseline and 1, 2, 3 year(s) after the switch to U-500 insulin
Body Weight baseline, 1-year, 2-years, 3-years Body Weight measured at baseline and 1, 2, 3 year(s) after the switch to U-500