Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CUMG - 090104KT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®). |
|
| 2 | Experimental | CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) | Drug | MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration. |
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathryn M Thrailkill, MD | Arkansas Children's Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital/Research Institute | Little Rock | Arkansas | 72202 | United States |
One subject in each group withdrew from further participation after initial randomization, possibly because of dissatisfaction with the assigned mode of treatment.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Insulin Pump Therapy, Started at Diagnosis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. | Per protocol | Posted | Mean | Standard Deviation | ng/mL | 12 months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitilized for treatment of Urinary tract infection | Renal and urinary disorders | Other | Systematic Assessment | Subject was hospitilized in a local hospital for initial treatment of symptoms of a urinary tract infection; discharged home on oral antibiotics, in good condition. Patient had a history of recurrent UTIs, prior to study enrollment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain/constipation | Gastrointestinal disorders | Other | Systematic Assessment |
Post hoc analysis demonstrated that the study design was weakened by an underestimation of the sample size per group needed to determine a statistically significant result for our primary outcome measure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Thrailkill, MD | Arkansas Children's Hospital Research Institute | 501-364-1430 | thrailkillkathrynm@uams.edu |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007328 | Insulin |
| D000069036 | Insulin Glargine |
| D061267 | Insulin Aspart |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CSII (Animas Corporation insulin pump, model IR 1200) | Device | CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200. |
|
|
| 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 |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Not Posted | 12 months | Participants |
| Secondary | Changes in Daily Insulin Requirements Over Time | Not Posted | 12 months | Participants |
| Secondary | Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis. | Not Posted | 12 months | Participants |
| Secondary | Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations. | Not Posted | 12 months | Participants |
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | 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. | 1 | 12 | 7 | 12 |
|
| Chest pain | Musculoskeletal and connective tissue disorders | other | Systematic Assessment |
|
| Pump malfunction | Investigations | Other | Systematic Assessment |
|
| Infections | Infections and infestations | Other | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Other | Systematic Assessment |
|
| pharyngitis | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment |
|
| Vision change | Eye disorders | Other | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Other | Systematic Assessment |
|
Not provided
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
| D061266 | Insulin, Short-Acting |