Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

NCT00574405 | Completed Results

• 2 other identifiers: 29256CUMG - 090104KT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Insulin pump; Beta cell

Outcome Measures

Primary Outcomes (1)

• Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.

  12 months

Secondary Outcomes (4)

• 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.

  12 months

• Changes in Daily Insulin Requirements Over Time

  12 months

• Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.

  12 months

• Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

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

2

EXPERIMENTAL

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

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

Interventions

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

MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.

Also known as: Novolog® or Humalog®

1

CSII (Animas Corporation insulin pump, model IR 1200) DEVICE

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

Also known as: Animas Corporation insulin pump, model IR 1200

2

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital/Research Institute

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin; Insulin Glargine; Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulin, Short-Acting

Limitations and Caveats

Post hoc analysis demonstrated that the study design was weakened by an underestimation of the sample size per group needed to determine a statistically significant result for our primary outcome measure.

Results Point of Contact

• Title: Kathryn Thrailkill, MD
• Organization: Arkansas Children's Hospital Research Institute

thrailkillkathrynm@uams.edu

501-364-1430

Study Officials

• Kathryn M Thrailkill, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 17, 2007
• Study Start: April 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 13, 2017
• Results First Posted: August 9, 2011

Record last verified: 2017-09

Locations

US (1)