Diabetes Mellitus
Conditions
Keywords
Insulin pump, Beta cell
Brief summary
Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.
Interventions
DRUGMDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])
MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
DEVICECSII (Animas Corporation insulin pump, model IR 1200)
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
Sponsors
Arkansas Children's Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Medical history and clinical presentation consistent with the diagnosis of Type 1 DM. * Age: 8-18 years
Exclusion criteria
* Clinical presentation consistent with Type 2 DM. * History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions. * Concurrent pregnancy. * Participation in other research protocols or use of other investigational agents within 30 days of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment. | 12 months |
| Changes in Daily Insulin Requirements Over Time | 12 months |
| Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis. | 12 months |
| Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations. | 12 months |
Countries
United States
Participant flow
Recruitment details
104 children with T1D were screened between 04/05-02/09; 64 declined to participate; 16 did not meet inclusion/exclusion criteria. 24 subjects (12 per group) were enrolled. 1 subject in each group withdrew after initial randomization. Of the remaining 22, 1 completed the 9-mo visit, 1 completed the 6-mo visit, and 1 completed the 1-mo visit.
Pre-assignment details
One subject in each group withdrew from further participation after initial randomization, possibly because of dissatisfaction with the assigned mode of treatment.
Participants by arm
| Arm | Count |
|---|---|
| Multiple Daily Injection Therapy Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis. | 12 |
| Insulin Pump Therapy, Started at Diagnosis. Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Insulin Pump Therapy, Started at Diagnosis. | Multiple Daily Injection Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.1 years STANDARD_DEVIATION 3.6 | 12.1 years STANDARD_DEVIATION 2.5 | 12.1 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 12 | 7 / 12 |
| serious Total, serious adverse events | 0 / 12 | 1 / 12 |
Outcome results
Primary
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
Time frame: 12 months
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multiple Daily Injection Therapy | Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. | 1.8 ng/mL | Standard Deviation 1.4 |
| Insulin Pump Therapy, Started at Diagnosis. | Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. | 3.1 ng/mL | Standard Deviation 2.2 |
Secondary
Changes in Daily Insulin Requirements Over Time
Time frame: 12 months
Secondary
Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.
Time frame: 12 months
Secondary
Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.
Time frame: 12 months
Secondary
Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.
Time frame: 12 months