- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03557892
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Firenze, Italy, 50134
- Diabetologia AOU Careggi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 1 diabetes
- Duration of diabetes > 2 years
- Current treatment with MDI, using insulin analogues as bolus and basal insulin
- HbA1c<64 mmol/mol
Exclusion Criteria:
- HbA1c>64 mmol/mol
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CSII+CGM
|
Animas Vibe Platinum insulin pump and Dexcom G4 CGM
|
ACTIVE_COMPARATOR: MDI with degludec
|
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 4 months
|
Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe Hypoglycemia
Time Frame: 4 months
|
Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase
|
4 months
|
Local Reactions
Time Frame: 4 months
|
Number of participants with local reactions at infusion/glucose monitoring site
|
4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1DM001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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