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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557892
• Other study ID #: T1DM001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 2, 2020

Study information

• Verified date: July 2022
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• CGM+CSII
Animas Vibe Platinum insulin pump and Dexcom G4 CGM
• MDI with degludec
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin

Locations

Country	Name	City	State
Italy	Diabetologia AOU Careggi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)	4 months
Secondary	Severe Hypoglycemia	Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase	4 months
Secondary	Local Reactions	Number of participants with local reactions at infusion/glucose monitoring site	4 months