Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00476788

Run by

University of Alabama at Birmingham

People needed

14

Starts

2007-04-01

Expected to finish

2009-09-01

Last updated by the study team

2017-04-17

Who can join

Age: 1 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Children's Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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