Type 1 Diabetes Mellitus
Conditions
Keywords
microneedle continuous subcutaneous insulin infusion
Brief summary
The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.
Interventions
DEVICEMicroneedle
Microneedle used to deliver insulin at a depth less than 900 micrometers
DEVICESubcutaneous insulin catheter
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Sponsors
Thrasher Research Fund
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 8 years of age * \<19 years of age * Type 1 Diabetes for at least 2 years * Uses a conventional, FDA-approved insulin pump for the past year * Uses Lispro insulin * Mean hemoglobin A1C ≤ 8.5 % for the past year * Body mass index ≤ 85th percentile for age * Understand and be willing to adhere to the study protocol
Exclusion criteria
* Type 2 Diabetes * Acanthosis nigricans * Clinically significant major organ system disease * On glucocorticoid therapy * Insulin requirement ≥ 150 U/day * Illness on the day of the study * Cognitive impairment (IQ \< 85 or \> 2 grades behind age-appropriate grade) * Pregnant or breast-feeding (if female).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset Time (Tmax) | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours | Average time to peak insulin concentration |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from our outpatient clinic setting within the Emory Children's Center
Pre-assignment details
In the event that the potential subject was on Humalog they switched to Novolog 48 hours prior to first visit.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 14.61 years STANDARD_DEVIATION 2.19 |
| Microneedle Female | 7 Participants |
| Microneedle Male | 9 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
| Subcutaneous insulin catheter Female | 7 participants |
| Subcutaneous insulin catheter Male | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Onset Time (Tmax)
Average time to peak insulin concentration
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedle | Onset Time (Tmax) | 30 Minutes | Standard Deviation 2 |
| Subcutaneous Insulin Catheter | Onset Time (Tmax) | 52 Minutes | Standard Deviation 4 |