Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)

NCT00357890 | Completed Results

• 1 other identifier: 16-03890-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).

Conditions

Diabetes Mellitus, Insulin-Dependent

Keywords

type 1 diabetes; diabetes; new onset; CSII; insulin sensitivity; beta cell function; beta cell preservation

Outcome Measures

Primary Outcomes (2)

• Insulin Sensitivity

  Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.

  24 months

• Beta Cell Function

  Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing

  24 months

Secondary Outcomes (2)

• Hemoglobin A1c

  24 months

• Percent Body Fat

  24 months

Study Arms (2)

Pump therapy (CSII)

EXPERIMENTAL

Use of pump therapy

Device: Insulin pump therapy

Multiple daily injections (MDI)

ACTIVE COMPARATOR

Use of MDI (basal bolus therapy with glargine)

Drug: Multiple daily injections using insulin glargine + rapid acting analog

Interventions

Insulin pump therapy DEVICE

CSII initiated within 1 month of diagnosis

Also known as: Continuous subcutaneous insulin infusion (CSII)

Pump therapy (CSII)

Multiple daily injections using insulin glargine + rapid acting analog DRUG

MDI as control

Also known as: MDI using glargine plus a rapid acting analog

Multiple daily injections (MDI)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female patient between the age of 12 and 17 years inclusive at time of entry into study (i.e., after their 12th but before their 18th birthday)
• Type 1 diabetes mellitus for no more than 10 days
• pubertal (Tanner stage 2 or above)
• The patient and parents or guardians should be able to do simple math calculations (necessary for pump management)
• Parent or legal guardian must give signed informed consent

You may not qualify if:

• No other chronic medical conditions (well-controlled thyroid disease is OK, and mild asthma is OK if the patient is not on chronic inhaled or oral daily corticosteroids)
• Exceptional psychological stress, more than expected for circumstances of having the new diagnosis of diabetes
• Inability or unwillingness to comply with requirements of the protocol

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Limitations and Caveats

Pilot study and thus sample size is small.

Results Point of Contact

• Title: Larry A Fox, MD
• Organization: Nemours Children's Health

larry.fox@nemours.org

9046973600

Study Officials

• Larry A Fox, MD

  Nemours Chidlren's Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 28, 2006
• Study Start: December 1, 2005
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 7, 2023
• Results First Posted: July 7, 2023

Record last verified: 2023-07

Locations

US (1)