Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes Mellitus |
Device: Omnipod Insulin Management System |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fast Track Continuous Subcutaneous Insulin Infusion (CSII) in Children With Newly Diagnosed Type 1 Diabetes Mellitus: An Evaluation of a Novel CSII Device in the Immediate Period Following Diagnosis of Type 1 Diabetes (T1DM) |
- A1c [ Time Frame: 6.9 months (average) ] [ Designated as safety issue: No ]Measure of glycemic control over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.
- Adverse Event Frequency [ Time Frame: 6.9 months (average) ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | April 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Omnipod Device
Patients will be placed on an Omnipod insulin pump
|
Device: Omnipod Insulin Management System
Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus
Other Name: Tubeless insulin pump
|
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.
Eligibility| Ages Eligible for Study: | 1 Year to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts 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).
Contacts and Locations| United States, Alabama | |
| Children's Hospital | |
| Birmingham, Alabama, United States, 35233 | |
| Principal Investigator: | Elaine C Moreland, MD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | Elaine Moreland MD, UAB |
| ClinicalTrials.gov Identifier: | NCT00476788 History of Changes |
| Other Study ID Numbers: | X060928006 |
| Study First Received: | May 18, 2007 |
| Results First Received: | October 12, 2010 |
| Last Updated: | December 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
pediatrics CSII diabetes C-peptide adverse events |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013