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

Azienda Ospedaliero-Universitaria Careggi

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: MDI with degludec; Device: CGM+CSII

Study type: Interventional

Funder types: Other

Identifiers

NCT03557892

T1DM001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

CSII+CGM

Experimental group

Treatment:

Device: CGM+CSII

MDI with degludec

Active Comparator group

Treatment:

Device: MDI with degludec