Trial Outcomes & Findings for Continuos Subcutaneous Insulin Infusion in Italy (NCT NCT02620917)

NCT ID: NCT02620917

Last Updated: 2020-04-08

Results Overview

median of HbA1c measured in the last year

• Recruitment status: COMPLETED
• Target enrollment: 6623 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-04-08

Participant Flow

Participant milestones

Measure	Continuous Subcutaneous Insulin Infusion (CSII) Treatment Patients who received Continuous subcutaneous insulin infusion (CSII) treatment in Italy
Overall Study STARTED	6623
Overall Study COMPLETED	6623
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuos Subcutaneous Insulin Infusion in Italy

Baseline characteristics by cohort

Measure	CSII Treatment n=6623 Participants Patients who received CSII treatment in Italy
Age, Continuous	37 years n=5 Participants
Sex: Female, Male Female	3827 Participants n=5 Participants
Sex: Female, Male Male	2796 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6623 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	6623 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

median of HbA1c measured in the last year

Outcome measures

Measure	CSII Treatment n=6623 Participants Patients who received CSII treatment in Italy	Paediatric Patients on CSII Treatment Patients \< 18 years old ON CSII treatment
Efficacy Assessed by Median of HbA1c,	60 mmol/mol Interval 53.0 to 67.0	—

PRIMARY outcome

Timeframe: 1year

Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year

Outcome measures

Measure	CSII Treatment n=6623 Participants Patients who received CSII treatment in Italy	Paediatric Patients on CSII Treatment Patients \< 18 years old ON CSII treatment
Patients With Severe Hypoglycemia	331 participants	—

PRIMARY outcome

Timeframe: 1 year

number of patients who achieved HbA1c target (< 7,5% in patients < 18 years old; <7% in adult patients);

Outcome measures

Measure	CSII Treatment n=5598 Participants Patients who received CSII treatment in Italy	Paediatric Patients on CSII Treatment n=1025 Participants Patients \< 18 years old ON CSII treatment
Number of Patients With Glycated Hemoglobin on Target	1288 participants	445 participants

SECONDARY outcome

Timeframe: 1 year

number of patients adults with HbA1c <7,0% using advanced pump's functions, CGM and CHO counting number of paediatrics patients with HbA1c < 7.5% using advanced pump's functions, CGM and CHO counting

Outcome measures

Measure	CSII Treatment n=5598 Participants Patients who received CSII treatment in Italy	Paediatric Patients on CSII Treatment n=1025 Participants Patients \< 18 years old ON CSII treatment
Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting	1713 participants	515 participants

Adverse Events

CSII Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniela Bruttomesso

University of Padova

Phone: 0039 049/8212183

Email: daniela.bruttomesso@unipd.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place