N/A
Completed N=12
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
Diabetes Mellitus, Insulin-Dependent
Source: ClinicalTrials.gov NCT00357890 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Insulin Sensitivity — 8.6; 6.2; 5.8; 4.8 mg/kg/min
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity |
8.6; 6.2; 5.8; 4.8 | — |
| PRIMARY Beta Cell Function |
2.1; 1.7; 1.1; 1.6 | — |
| SECONDARY Hemoglobin A1c |
10; 10.2; 6.1; 7.0; 6.8; 7.5 | — |
| SECONDARY Percent Body Fat |
20; 21.6; 18.5; 20.3; 17.4; 20.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00357890). 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.