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Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes

NCT03557892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-07-26

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

CGM+CSII

Animas Vibe Platinum insulin pump and Dexcom G4 CGM

DEVICE

MDI with degludec

Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-12-20
Completion
2020-01-02

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557892 on ClinicalTrials.gov