Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes
Continuous Subcutaneous Insulin Infusion Associated With Continuous Glucose Monitoring in Comparison With Subcutaneous Multi-injection Insulin Therapy Using Degludec as Basal Insulin: a Randomized Crossover Trial in Type 1 Diabetes
1 other identifier
interventional
28
1 country
1
Brief Summary
Several studies have shown that Continuous Subcutaneous Insulin Infusion together with Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec. This study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1 diabetes. A crossover design was chosen in order to minimize study sample improving statistical power.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
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
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2020
CompletedResults Posted
Study results publicly available
July 21, 2022
CompletedJuly 26, 2022
July 1, 2022
1.7 years
June 5, 2018
January 12, 2021
July 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)
4 months
Secondary Outcomes (2)
Severe Hypoglycemia
4 months
Local Reactions
4 months
Study Arms (2)
CSII+CGM
EXPERIMENTALMDI with degludec
ACTIVE COMPARATORInterventions
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Eligibility Criteria
You may qualify if:
- Type 1 diabetes
- Duration of diabetes \> 2 years
- Current treatment with MDI, using insulin analogues as bolus and basal insulin
- HbA1c\<64 mmol/mol
You may not qualify if:
- HbA1c\>64 mmol/mol
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetologia AOU Careggi
Florence, 50134, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Ilaria Dicembrini
- Organization
- University of Florence Medical School and AOU Careggi
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Diabetology
Study Record Dates
First Submitted
June 5, 2018
First Posted
June 15, 2018
Study Start
April 1, 2018
Primary Completion
December 20, 2019
Study Completion
January 2, 2020
Last Updated
July 26, 2022
Results First Posted
July 21, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share