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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin 1 | Active Comparator | Either insulin Aspart or insulin Lispro were randomized to be insulin 1. |
|
| Insulin 2 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 to 100 hours after last pump infusion line change |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 to 100 hours after keeping the same pump infusion line in place |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivian A Fonseca, MD, FRCP | Tulane Universtiy Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Translational Unit - Tulane School of Medicine | New Orleans | Louisiana | 70112 | United States |
There was no run -in or transition before starting the test period. However, there was a wash out period of up to 2 weeks between the 2 test periods.
Patients with Type I diabetes mellitus using an insulin pump were recruited from the outpatient clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspart First, Washout, Then Lispro | Patients used Aspart Insulin for up to 100 hours, then entered a two week wash out period, then used Lispro insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study. |
| FG001 | Lispro First, Washout, Then Aspart | Patients used Lispro Insulin for up to 100 hours, then entered a two week wash out period, then used Aspart insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 |
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| Washout |
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| Intervention 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | These are the characteristics of the entire study population. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was per protocol, intention to treat. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin. | Posted | Number | Participants | 24 to 100 hours after last pump infusion line change |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Aspart | Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina K. Thethi, MD, MPH | Tulane University Health Sciences Center | 504-988-5044 | tthethi@tulane.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Insulin Lispro | Drug | Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2. |
|
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| 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. |
| Between 48, 72 and 96 hours after the last pump infusion line change |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Insulin Lispro | Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | µg/ml | 48 to 100 hours after keeping the same pump infusion line in place |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pg/ml | Between 48, 72 and 96 hours after the last pump infusion line change |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Insulin Lispro | Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro. | 0 | 20 | 0 | 20 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |