Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
TRANSITION: Insulin Pump to MDI with Degludec
NCT03987191Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2020
- Primary completion
- Oct 2020
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- insulin degludec
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 4, randomised, open-label trial of insulin degludec in type 1 diabetes mellitus (T1D) (2 arms), sponsored by University of Colorado Denver. Primary endpoint: Time Spent With CGM Glucose Levels >180mg/dl at 7 days. Started Jan 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard of Care Transition
Stop pump, start Degludec 1:1 + Aspart
Investigational Transition
Start Degludec 1:1 + Aspart, taper pump over 48h
03
Who it enrols
Adults with Type 1 Diabetes on insulin pump therapy for at least 6 months with HbA1c between 6.5% and 8.5%.
04
Endpoints
Primary
Time Spent With CGM Glucose Levels >180mg/dl
Secondary
Time Spent in CGM-measured Time-in-range (Glucose Levels >=70 mg/dl and <=180 mg/dl)
Time Spent in CGM-measured Hypoglycemia < 70 mg/dl
Number of Participants With Severe Hypoglycemia and Severe Hyperglycemia
Number of Boluses (Correction Boluses)
Insulin Delivery Satisfaction (IDSS Survey)
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire)
Beyond the preview
Go deeper on NCT03987191.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03987191.