NCT03338439

Brief Summary

The aim of this study was to evaluate if the positive effects recorded on glycemic control with CSII were maintained on the long term compared to multi-daily injections (MDI). The secondary objective was to evaluate if there is a reduction of type and number of cardiovascular events (CV) in CSII group compared to MDI group after 8 years of observation. This retrospective, observational trial evaluated 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

November 2, 2017

Last Update Submit

November 6, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (9)

  • Fasting glycemia

    Carbohydrate metabolism

    Change from Baseline, at 4 years and at 8 years

  • Postprandial glycemia

    Carbohydrate metabolism

    Change from Baseline, at 4 years and at 8 years

  • Glycated haemoglobin

    Index of glycemic compensation

    Change from Baseline, at 4 years and at 8 years

  • Total Cholesterol

    Lipid metabolism

    Change from Baseline, at 4 years and at 8 years

  • HDL-Cholesterol

    Lipid metabolism

    Change from Baseline, at 4 years and at 8 years

  • Triglycerides

    Lipid metabolism

    Change from Baseline, at 4 years and at 8 years

  • LDL-Cholesterol

    Lipid metabolism

    Change from Baseline, at 4 years and at 8 years

  • Systolic Blood Pressure

    Haemodynamic parameter

    Change from Baseline, at 4 years and at 8 years

  • Diastolic Blood Pressure

    Haemodynamic parameter

    Change from Baseline, at 4 years and at 8 years

Secondary Outcomes (7)

  • Cardiovascular event

    Change from Baseline, at 4 years and at 8 years

  • Cardiovascular event

    Change from Baseline, at 4 years and at 8 years

  • Cardiovascular event

    Change from Baseline, at 4 years and at 8 years

  • Cardiovascular event

    Change from Baseline, at 4 years and at 8 years

  • Cardiovascular event

    Change from Baseline, at 4 years and at 8 years

  • +2 more secondary outcomes

Study Arms (2)

CSII

CSII: patients with continuous subcutaneous insulin infusion

Device: CSII

MDI

MDI: patients with multi-daily injections

Interventions

CSIIDEVICE

This retrospective, observational trial will evaluate 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.

CSII

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with type 1 and type 2 diabetes mellitus taking insulin

You may qualify if:

  • patients with type 1 or 2 diabetes with prior treatment with MDI initiating CSII therapy with tubed insulin pumps
  • patients type 1 or 2 diabetes with prior treatment with MDI continuing MDI
  • patients attending the center for at least 8 years

You may not qualify if:

  • patients not taking insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo Foundation

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 9, 2017

Study Start

July 1, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)