| Trial ID: | L2171 |
| Source ID: | NCT02548494
|
| Associated Drug: |
Glargine
|
| Title: |
Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Diabetic Ketoacidosis
|
| Interventions: |
DRUG: Glargine|DRUG: IV insulin|OTHER: Electrolyte Correction|OTHER: Correction of Fluid Loss
|
| Outcome Measures: |
Primary: Blood glucose, Within 3 hrs of arrival | Secondary: Blood glucose, checking for changes in levels after intervention initiation, 4 hours after intervention initiation|blood pH, within 3 hours of arrival|blood pH, checking for changes in levels after intervention initiation, 4 hours after intervention initiation|blood bicarbonate level, Within 3 hrs of arrival|blood bicarbonate level, checking for changes in levels after intervention initiation, 4 hours after intervention initiation|Urinalysis for levels of ketones & glucosuria, Within 3 hrs of arrival|Urinalysis for levels of ketones & glucosuria, checking for changes in levels after intervention initiation, 4 hours after intervention initiation | Other: Length of PICU Stay, 1-2 days|Length of Hospital Stay, 1-5 days|Hypoglycemic events, Hypoglycemia is defined as blood glucose less than 70 mg/dL., length of hospital stay, an expected average of 3 days
|
| Sponsor/Collaborators: |
Sponsor: Chattanooga-Hamilton County Hospital Authority
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
17
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-11
|
| Completion Date: |
2019-02-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-09-23
|
| Locations: |
Children's @ Erlanger, Chattanooga, Tennessee, 37403, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02548494
|
