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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

CGM+CSII

MDI with degludec

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Diabetologia AOU Careggi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CSII+CGM

MDI with degludec

Arm Description

Outcomes

Primary Outcome Measures

HbA1c

Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)

Secondary Outcome Measures

Severe Hypoglycemia

Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase

Local Reactions

Number of participants with local reactions at infusion/glucose monitoring site

Full Information

NCT ID

NCT03557892

First Posted

June 5, 2018

Last Updated

July 20, 2022

Sponsor

Azienda Ospedaliero-Universitaria Careggi

1. Study Identification

Unique Protocol Identification Number

NCT03557892

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

December 20, 2019 (Actual)

Study Completion Date

January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CSII+CGM

Arm Type

Experimental

Arm Title

MDI with degludec

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

CGM+CSII

Intervention Description

Animas Vibe Platinum insulin pump and Dexcom G4 CGM

Intervention Type

Device

Intervention Name(s)

MDI with degludec

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1c

Description

Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Severe Hypoglycemia

Description

Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase

Time Frame

4 months

Title

Local Reactions

Description

Number of participants with local reactions at infusion/glucose monitoring site

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Diabetologia AOU Careggi

City

Firenze

ZIP/Postal Code

50134

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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