Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, CSII
Brief summary
This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.
Detailed description
The aim of the study is to collect clinical and metabolic characteristics of patient treated with CSII in Italy. Data will be collected through a questionnaire sent by e-mail to CSII experienced Diabetes Centers ( both adult and pediatric patients) . The questionnaire assessed: (1) number of CSII-treated patients; (2) patients and pump characteristics; (3) structure and organization of Diabetes Centers providing CSII therapy; (4) metabolic control.
Interventions
None listed
Sponsors
University of Padova
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* all patients treated with CSIIin Italy
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessed by Median of HbA1c, | 1 year | median of HbA1c measured in the last year |
| Patients With Severe Hypoglycemia | 1year | Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year |
| Number of Patients With Glycated Hemoglobin on Target | 1 year | number of patients who achieved HbA1c target (\< 7,5% in patients \< 18 years old; \<7% in adult patients); |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting | 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 |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CSII Treatment Patients who received CSII treatment in Italy | 6,623 |
| Total | 6,623 |
Baseline characteristics
| Characteristic | CSII Treatment |
|---|---|
| Age, Continuous | 37 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6623 Participants |
| Region of Enrollment Italy | 6623 participants |
| Sex: Female, Male Female | 3827 Participants |
| Sex: Female, Male Male | 2796 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6,223 |
| other Total, other adverse events | 0 / 6,223 |
| serious Total, serious adverse events | 0 / 6,223 |
Outcome results
Primary
Efficacy Assessed by Median of HbA1c,
median of HbA1c measured in the last year
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CSII Treatment | Efficacy Assessed by Median of HbA1c, | 60 mmol/mol |
Primary
Number of Patients With Glycated Hemoglobin on Target
number of patients who achieved HbA1c target (\< 7,5% in patients \< 18 years old; \<7% in adult patients);
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSII Treatment | Number of Patients With Glycated Hemoglobin on Target | 1288 participants |
| Paediatric Patients on CSII Treatment | Number of Patients With Glycated Hemoglobin on Target | 445 participants |
Primary
Patients With Severe Hypoglycemia
Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year
Time frame: 1year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSII Treatment | Patients With Severe Hypoglycemia | 331 participants |
Secondary
Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting
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
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSII Treatment | Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting | 1713 participants |
| Paediatric Patients on CSII Treatment | Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting | 515 participants |