Arkansas Children's Hospital/Research Institute
Little Rock, Arkansas, 72202, United States
NCT Number: NCT00574405
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.
Looking for future studies?
Notify Me8 year–18 year
All sexes
Interventional
Not applicable
Little Rock, Arkansas, 72202, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
Other names: Novolog® or Humalog®
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
Other names: Animas Corporation insulin pump, model IR 1200
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Arkansas Children's Hospital Research Institute
Other
Acronym: ktpump
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00038727
Body Weight, CVD
Rockville, Maryland, United States
View Trial DetailsNCT06029517
Arterial Occlusive Diseases, Arteriosclerosis
Buffalo, New York, United States
View Trial DetailsNCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT07728162
Diabetes Mellitus, Disease Attributes
Bolu, Turkey (Türkiye)
View Trial Details