Clinical trial NCT00574405: Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Official title: Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Insulin pump
Beta cell
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Medical history and clinical presentation consistent with the diagnosis of Type 1 DM.
* Age: 8-18 years

Exclusion Criteria:

* Clinical presentation consistent with Type 2 DM.
* History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions.
* Concurrent pregnancy.
* Participation in other research protocols or use of other investigational agents within 30 days of enrollment.

Primary outcomes:
measure: Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: Changes in Daily Insulin Requirements Over Time
timeFrame: 12 months
measure: Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.
timeFrame: 12 months
measure: Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.
timeFrame: 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital/Research Institute
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Kathryn M Thrailkill, MD
role: PRINCIPAL_INVESTIGATOR
References: