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N/A Completed N=24 Randomized Treatment

Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Source: ClinicalTrials.gov NCT00574405 ↗
Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Aug 2011
Primary outcomePrimary: Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. — 1.8; 3.1 ng/mL

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
1.8; 3.1 —
SECONDARY
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.
— —
SECONDARY
Changes in Daily Insulin Requirements Over Time
— —
SECONDARY
Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.
— —
SECONDARY
Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.
— —

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00574405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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