Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy (ktpump)

Arkansas Children's Hospital Research Institute

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]); Device: CSII (Animas Corporation insulin pump, model IR 1200)

Study type: Interventional

Funder types: Other

Identifiers

NCT00574405

CUMG - 090104KT

29256

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

1

Active Comparator group

Description:

MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®).

Treatment:

Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])

2

Experimental group

Description:

CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

Treatment:

Device: CSII (Animas Corporation insulin pump, model IR 1200)