Clinical trial NCT04371497: Switch From U-100 Insulin Analog to U-500 Regular Insulin in Pumps for Type 2 Diabetes
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
Insulin Resistance
Continuous Subcutaneous Insulin Infusion
Insulin Pump
Concentrated Insulin
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: differential HbA1c before and after insulin switch
timeFrame: baseline, 1-year, 2-years, 3-years
Secondary outcomes:
measure: Total Daily Insulin Dose
timeFrame: baseline, 1-year, 2-years, 3-years
measure: Body Weight
timeFrame: baseline, 1-year, 2-years, 3-years
measure: Lipids
timeFrame: baseline, 1-year, 2-years, 3-years
measure: Hypoglycemia events
timeFrame: baseline, 1-year, 2-years, 3-years
measure: Continuous Glucose Monitoring before and after insulin switch
timeFrame: baseline, 6-month
Other outcomes:
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