| Trial ID: | L7222 |
| Source ID: | NCT02680054
|
| Associated Drug: |
Insulin, Asp(B28)-
|
| Title: |
Additional Insulin for Fat and Protein in Children With Diabetes Study
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02680054/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Insulin, Asp(B28)-
|
| Outcome Measures: |
Primary: Peak Glucose Level Following Test Meal, Glucose measured on the continuous subcutaneous glucose monitor, assessed up to 12 hours following the test meal|Peak Glucose Excursion From Baseline Following Test Meal, Glucose measured on the continuous subcutaneous glucose monitor, assessed up to 12 hours following the test meal|Time of Peak Glucose Level Following Test Meal, Glucose measured on the continuous subcutaneous glucose monitor, assessed up to 12 hours following the test meal | Secondary: Number of Participants With Hypoglycaemia Events Following the Insulin Dosing, All episodes of hypoglycaemia (BG less than 4 mmol/l) either on continuous glucose monitor or self-monitoring of BG, assessed up to 12 hours following the test meal | Other: Acceptability of Giving Insulin at Different Times Related to Test Meal, Would young people continue to give extra insulin injections for High Fat High Protein (HFHP) meals, questionnaires completed up to a week after the test meals
|
| Sponsor/Collaborators: |
Sponsor: Oxford University Hospitals NHS Trust
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-02
|
| Completion Date: |
2018-08-31
|
| Results First Posted: |
2020-02-05
|
| Last Update Posted: |
2020-02-05
|
| Locations: |
Royal Berkshire Hospital, Reading, Berkshire, United Kingdom|Oxford Children's Hospital, John Radcliffe Hospital, Oxford, Oxon, OX3 9DU, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02680054
|
