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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: CGM+CSII; Device: MDI with degludec

• Registration Number: NCT03557892
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Primary Completion: 2019-12-20
• Study Completion: 2020-01-02
• Results First Submitted: 2021-01-12
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-19
• Last Update Submitted: 2022-07-20
• Results First Posted: 2022-07-21
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CSII+CGM	CGM+CSII	-
MDI with degludec	MDI with degludec	-

Primary Outcome Measures

Name	Time	Method
HbA1c	4 months	Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)

Secondary Outcome Measures

Name	Time	Method
Local Reactions	4 months	Number of participants with local reactions at infusion/glucose monitoring site
Severe Hypoglycemia	4 months	Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase

Trial Locations

Locations (1)

Diabetologia AOU Careggi; 🇮🇹 Firenze, Italy