N/A
N=24
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00574405 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Aug 2011
Primary outcome: 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 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) (Drug); CSII (Animas Corporation insulin pump, model IR 1200) (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Arkansas Children's Hospital Research Institute
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-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. |
— | — |
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.
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.