Diabetes Mellitus, Type 1 MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -You are diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months -You are 18 years of age or older -You have been using an insulin pump with ‘rapid-acting insulin’ for at least 6 months and using the same rapid-acting insulin for at least the past 30 days -You have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months -You have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump for at least the past 30 days Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: You have had more than 1 emergency treatment for very low blood glucose in the last 6 months. You have had more than 1 emergency treatment for poor glucose control in the last 6 months. You are taking certain diabetes medications that are not allowed for study participation. You have major problems with your heart, kidneys, liver, or you have a blood disorder. You have had or are now being treated for certain types of cancer that prevents you from study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1-To compare LY900014 and insulin lispro with respect to the rate of suspected infusion set occlusions defined as unexplained hyperglycemia with blood glucose > 300 mg/dL (16.7 mmol/L) that does not decrease by >50 mg/dL (2.8 mmol/L) following a correction insulin bolus delivered via the pump and that leads to an infusion set change;Secondary Objective: To compare LY900014 and insulin lispro with respect to: 2.Incidence of suspected infusion set occlusions defined as unexplained hyperglycemia with blood glucose >300 mg/dL (16.7 mmol/L) that does not decrease by >50 mg/dL (2.8 mmol/L) following a correction insulin bolus delivered via the pump and that leads to an infusion set change 3.Rate and incidence of any suspected infusion set occlusions defined as unexplained hyperglycemia that leads to an infusion set change 4.Rate and incidence of premature infusion set changes by reason 5.Days until infusion set change 6.Total, basal, and bolus insulin dose 7.Interstitial glucose reduction rate from hyperglycemia following a non-meal-related correction insulin bolus delivered via the pump 8.Rate of severe hypoglycemic events;Primary end point(s): 1-Rate (events/patient/30 days) of suspected infusion set occlusions defined as unexplained hyperglycemia with blood glucose (SMBG) >300 mg/dL (16.7 mmol/L) that does not decrease by >50 mg/dL (2.8 mmol/L) following a correction bolus delivered via the pump and that leads to an infusion set change during the 6-week treatment period;Timepoint(s) of evaluation of this end point: during the 6-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 2_during the 6-week treatment period 3_during the 6-week treatment period 4_during the 6-week treatment period 5_during the 6-week treatment period 6_ at the end of the 6-week treatment period 7_from up to 6 weeks of CGM use 8_during the 6-week treatment period;Secondary end point(s): 2-Incidence (percent of patients with at least 1 event) of suspected infusion set occlusions defined as unexplained hyperglycemia with blood glucose (SMBG) >300 mg/dL (16.7 mmol/L) that does not decrease by >50 mg/dL (2.8 mmol/L) following a correction bolus delivered via the pump and that leads to an infusion set change during the 6-week treatment period 3-Rate (events/patient/30 days) and incidence of any suspected infusion set occlusions defined as unexplained hyperglycemia that leads to an infusion set change during the 6-week treatment period 4-Rate (events/patient/30 days) and incidence of premature infusion set changes by reason during the 6-week treatment period 5-Days until infusion set change during the 6 week treatment period 6-Bolus/total insulin dose ratio at the end of the 6-week treatment period 7-Interstitial glucose reduction rate (glucose reduction [mg/dL and mmol/L] per minute) within 4 hours following a non-meal-related correction insulin bolus via the pump, from hyperglycemia (interstitial glucose >180 mg/dL (10.0 mmol/L) to recovery (interstitial glucose =180 mg/dL), from up to 6 weeks of CGM use 8-Rate (events/patient/100 years) of severe hypoglycemic events during the 6-week treatment period | — |
Countries
Spain, United States
Contacts
Public ContactGracia Montes
Lilly S.A.
Outcome results
None listed