Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump
BOLUS
Comparison of Injection of an Analogue Bolus of Insulin Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump.
2 other identifiers
interventional
22
1 country
1
Brief Summary
The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication. In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal). However, many patients perform their bolus after the meal. However this insulin administration modality is not clearly studied in the literature.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 3, 2025
April 1, 2016
6 months
September 9, 2015
November 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under Curve (AUC) of glycemia
Area Under Curve (AUC) recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia)
During 14 days
Secondary Outcomes (2)
Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability
During 14 days
Area Under Curve (AUC) during 4H after a high-fat meal
4 hours
Study Arms (2)
Group 1
EXPERIMENTALPatients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF). Intervention: drug (insulin Aspart)
Group 2
EXPERIMENTALPatients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE). Intervention: drug (insulin Aspart)
Interventions
Injection of Insulin Aspart before or after meals
Eligibility Criteria
You may qualify if:
- Major patients with type 1 diabetes treated with insulin pump.
You may not qualify if:
- Unbalanced diabetes,
- Ongoing pregnancy known,
- Gastrointestinal neuropathy known,
- Chronic medical illness and psychiatric
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Brest
Brest, 29200, France
Related Publications (1)
Thuillier P, Sonnet E, Alavi Z, Roudaut N, Nowak E, Dion A, Kerlan V. Comparison between preprandial vs. postprandial insulin aspart in patients with type 1 diabetes on insulin pump and real-time continuous glucose monitoring. Diabetes Metab Res Rev. 2018 Sep;34(6):e3019. doi: 10.1002/dmrr.3019. Epub 2018 Jun 1.
PMID: 29749032RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 10, 2015
Study Start
September 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
December 3, 2025
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share