Type 1 Diabetes Mellitus
Conditions
Keywords
pediatrics, CSII, diabetes, C-peptide, adverse events
Brief summary
This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The outcomes of interest are the feasibility and potential metabolic benefits of this approach. We anticipate that the initiation of this CSII device in the immediate post-diagnosis period in this population will result in good glycemic control and greater parental satisfaction when compared to intensive insulin injection therapy.
Detailed description
The incidence of type 1 diabetes (T1DM) is on the rise worldwide, especially in children younger than six years of age. Glycemic control using multiple daily injection (MDI) therapy can be difficult to achieve and maintain in the very young, especially in the immediate post-diagnosis period. This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The outcomes of interest are the feasibility, safety, and potential metabolic benefits of this approach. We will recruit 14 pediatric patients, aged one to ten years, from a pool of all children newly diagnosed with T1DM admitted to the Children's Hospital of Alabama to use the pump.General diabetes education and CSII-specific training will take place in a series of outpatient sessions with the PI and study nurse. Pump therapy will be initiated within two months of diagnosis providing that all requisite education and training has been successfully completed. Data will be collected for both study group and control group patients for six months via phone calls and monthly clinic visits. Areas which will be evaluated include glycemic control, residual endogenous insulin secretion, frequency of severe adverse events, parental distress, insulin needs, and physical growth. While initiating CSII in the immediate post-diagnosis period in this population may be initially time-intensive, it is anticipated that it will ultimately become time-saving because of the greater ease in blood sugar management.
Interventions
DEVICEOmnipod Insulin Management System
Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 1 through 10 years of age * Patients present to the Children's Hospital of Alabama with a new diagnosis of type 1 diabetes * Patients may be admitted to the inpatient unit * OR from the ER * OR or from an outside facility to Children's Hospital * Or seen in our outpatient clinic for the first time having been diagnosed at an outside facility * If patients are recruited from the outside facility in our outpatient clinic, the diagnosis must have been made within two weeks of the visit. Twenty patients and twenty control subjects will be recruited over a six-month period.
Exclusion criteria
* Patients with diabetes due to other causes (neonatal diabetes, pancreatitis, cystic fibrosis, etc.) * Patients will younger than 2 years of age * Patients older than 8 years of age * Lack any presence of other systemic disease(s), such as neoplastic disease or renal failure. * Patients must have adequate parental support and stable home environment (e.g. children in foster care or with a history of suspected abuse or neglect would be excluded).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Glycated Hemoglobin (A1c) | 6.9 months (average) | Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Reported Adverse Events | 6.9 months (average) | adverse events are defined as a change from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omnipod Device Patients will be placed on an Omnipod insulin pump | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Omnipod Device |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6.275 years STANDARD_DEVIATION 2.875 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Mean Glycated Hemoglobin (A1c)
Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.
Time frame: 6.9 months (average)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnipod Device | Mean Glycated Hemoglobin (A1c) | 7.6 percentage of glycated hemoglobin | Standard Deviation 1 |
Secondary
Number of Reported Adverse Events
adverse events are defined as a change from baseline
Time frame: 6.9 months (average)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnipod Device | Number of Reported Adverse Events | 0 events |