Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 diabetes mellitus, Glycemic control, Continuous subcutaneous insulin infusion, Continuous glucose monitoring system
Brief summary
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.
Detailed description
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. 1. Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum 1,5-anhydroglucitol. 2. Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared. 3. The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control. 4. Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.
Interventions
DRUGInsulin Aspart
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.
DRUGInsulin Lispro
Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
Sponsors
Tulane University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes treated with a pump for at least 3 months
Exclusion criteria
* Pregnancy * Plasma Creatinine \> 1.2 mg/dl * Inability to give informed consent * HbA1c \> 8% * Known or suspected hypersensitivity to trial drugs or any of their components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change | 24 to 100 hours after last pump infusion 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place | 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. |
| Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place | Between 48, 72 and 96 hours after the last pump infusion line change | 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. |
Countries
United States
Participant flow
Recruitment details
Patients with Type I diabetes mellitus using an insulin pump were recruited from the outpatient clinics.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population These are the characteristics of the entire study population. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 14.3 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 24 to 100 hours after last pump infusion line change
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Aspart | Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change | 17 Participants |
| Insulin Lispro | Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change | 16 Participants |
Comparison: Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.p-value: 0.5295% CI: [87.9, 100]Regression, Linear
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.
Time frame: 48 to 100 hours after keeping the same pump infusion line in place
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Aspart | Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place | 5.1 µg/ml | Standard Deviation 4.13 |
| Insulin Lispro | Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place | 5.6 µg/ml | Standard Deviation 4.2 |
Comparison: All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.p-value: 0.1595% CI: [0.97, 9.23]Regression, Linear
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.
Time frame: Between 48, 72 and 96 hours after the last pump infusion line change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Aspart | Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place | 6.9 pg/ml | Standard Deviation 2.5 |
| Insulin Lispro | Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place | 6.5 pg/ml | Standard Deviation 2.2 |
Comparison: All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.p-value: 0.5595% CI: [4.4, 9.4]Regression, Linear