Type 1 DiabetesIMITA2NCT02620917

Continuos Subcutaneous Insulin Infusion in Italy

An observational study of Type 1 Diabetes, run by University of Padova at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy. Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 1 Diabetes
How many people: 6,623 participants
Where: 1 siteItaly
Study dates: 1 Nov 2015to 1 Dec 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: we will evaluate allItalian patients treated with insulin pump

Who may be able to join

all patients treated with CSIIin Italy

Who cannot join

none

Trial locations and contacts

1 site in 1 country.

Italy1 site

University of Padova
Padova

Other trials in Italy

About this study

Official title: Survey on Continuos Subcutaneous Insulin Infusion in Italy

This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.

Read the 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.

Conditions: Type 1 Diabetes
Keywords: type 1 diabetes, CSII
Medical subject headings: Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy Assessed by Median of HbA1c,
median of HbA1c measured in the last year
Measured: 1 year
Patients With Severe Hypoglycemia
Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year
Measured: 1year
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);
Measured: 1 year

Secondary outcomes (1)

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
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20151 Dec 2017

First posted3 Dec 2015 (estimated)
Study start1 Nov 2015
Primary completion1 Dec 2017
Study completion1 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 6,623 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02620917
Sponsor's protocol ID: 3506/AO/15
Acronym: IMITA2
Status last verified: Mar 2020
First submitted: 23 Nov 2015
Last updated: 8 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lepore G, Bonfanti R, Bozzetto L, Di Blasi V, Girelli A, Grassi G, Iafusco D, Laviola L, Rabbone I, Schiaffini R, Bruttomesso D; Italian Study Group on the Diffusion of CSII. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):335-342. doi: 10.1016/j.numecd.2017.12.001. Epub 2017 Dec 9.
PubMed 29428572

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survey on Continuos Subcutaneous Insulin Infusion in Italy
ClinicalTrials.gov ID: NCT02620917
Acronym / sponsor ID: IMITA2 / 3506/AO/15
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes, CSII
Study type: Observational
Recruitment status: Completed
Enrolment: 6,623 participants (actual)
Lead sponsor: University of PadovaUniversity, hospital or other
Study start: 1 Nov 2015 (actual)
Primary completion: 1 Dec 2017 (actual)
Study completion: 1 Dec 2017 (actual)
First posted: 3 Dec 2015 (estimated)
Results: Posted 8 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: we will evaluate allItalian patients treated with insulin pump

Key inclusion criteria (1 listed)

all patients treated with CSIIin Italy

Key exclusion criteria (1 listed)

none

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Efficacy Assessed by Median of HbA1c,
Time frame: 1 year
median of HbA1c measured in the last year
Patients With Severe Hypoglycemia
Time frame: 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
Time frame: 1 year
number of patients who achieved HbA1c target (< 7,5% in patients < 18 years old; <7% in adult patients);

1 secondary outcome

Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting
Time frame: 1 year

Results and safety

Results posted to the registry on 8 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Subcutaneous Insulin Infusion (CSII) Treatment	6,623	6,623

Primary outcome: Efficacy Assessed by Median of HbA1c,

Time frame: 1 year. Median (Inter-Quartile Range). Unit: mmol/mol

Measure	CSII Treatment n = 6623
Value	60 (53 to 67)

Primary outcome: Patients With Severe Hypoglycemia

Time frame: 1year. Number. Unit: participants

Measure	CSII Treatment n = 6623
Value	331

Primary outcome: Number of Patients With Glycated Hemoglobin on Target

Time frame: 1 year. Number. Unit: participants

Measure	Adults on CSII Treatment n = 5598	Paediatric Patients on CSII Treatment n = 1025
Value	1288	445

1 secondary outcome is reported in the full results.

Adverse events

Time frame: time of observations= 1 years.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CSII Treatment	0 of 6,223 (0%)	0 of 6,223 (0%)	0 of 6,223

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29428572Lepore G, Bonfanti R, Bozzetto L, Di Blasi V, Girelli A, Grassi G, Iafusco D, Laviola L, Rabbone I, Schiaffini R, Bruttomesso D; Italian Study Group on the Diffusion of CSII. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):335-342. doi: 10.1016/j.numecd.2017.12.001. Epub 2017 Dec 9.

Related trials for Type 1 Diabetes

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
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RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniela Bruttomesso, MD, PhD principal investigator

University of Padova

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by University of Padova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Assessed by Median of HbA1c, (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02620917, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.