A Phase 4 interventional study of Insulin Aspart and Insulin Lispro in Type 1 Diabetes Mellitus, sponsored by Tulane University Health Sciences Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Tulane University Health Sciences Center · Phase 4, Interventional, and Treatment
The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.
Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations.
One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS) and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines.
The different variables will be compared between the two insulins using a paired t test.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Tulane University Health Sciences Center is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Either insulin Aspart or insulin Lispro were randomized to be insulin 1.
Drug: Insulin Aspart
Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study.
Drug: Insulin Lispro
Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.
Also known as: Insulin lispro - insulin Humalog, Insulin aspart - insulin Novolog
Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
Also known as: Insulin Aspart
Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change
For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level \>300 mg/dL.
Time frame: 24 to 100 hours after last pump infusion line change
Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place
Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.
Time frame: 48 to 100 hours after keeping the same pump infusion line in place
Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place
Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.
Time frame: Between 48, 72 and 96 hours after the last pump infusion line change
Patients with Type I diabetes mellitus using an insulin pump were recruited from the outpatient clinics.
| Milestone | Aspart First, Washout, Then Lispro | Lispro First, Washout, Then Aspart |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Aspart First, Washout, Then Lispro | Lispro First, Washout, Then Aspart |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Aspart First, Washout, Then Lispro | Lispro First, Washout, Then Aspart |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level \>300 mg/dL.
| Participants | Insulin Aspart | Insulin Lispro |
|---|---|---|
| Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change | 17 | 16 |
Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.
| µg/ml | Insulin Aspart | Insulin Lispro |
|---|---|---|
| Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place | 5.1 ± 4.13 | 5.6 ± 4.2 |
Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.
| pg/ml | Insulin Aspart | Insulin Lispro |
|---|---|---|
| Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place | 6.9 ± 2.5 | 6.5 ± 2.2 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Aspart | — | 0/20 (0%) | 0/20 (0%) |
| Insulin Lispro | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 45.5 ± 14.3 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 16 |
| Male | 4 |
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Tulane University Health Sciences Center