NCT03793283

Brief Summary

Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

December 27, 2018

Last Update Submit

January 15, 2020

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Concentration of Hemoglobin A1C (HbA1C).

    Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.

    1 year

Secondary Outcomes (13)

  • Hypoglycemia frequency.

    1 year

  • Concentration of Capillary blood glucose.

    1 year

  • Concentration of Interstitial blood glucose.

    1 year

  • Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.

    1 year

  • Glycemic variability: standar deviation of capilary/interstitial blood glucose.

    1 year

  • +8 more secondary outcomes

Study Arms (2)

Continous Subcutaneous Insulin Infusion

All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII. Forty-five patients are actually treated with CSII in our hospital.

Device: CSII

Multiple dose insulin injections (MDI):

Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI. MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.

Drug: Multiple dose insulin injections

Interventions

CSIIDEVICE

Currently receiving CSII therapy during 6 or more months.

Also known as: Continuous subcutaneous insulin infusion
Continous Subcutaneous Insulin Infusion
Multiple dose insulin injectionsDRUG

Currently receiving MDI therapy during 6 or more months.

Also known as: MDI
Multiple dose insulin injections (MDI):

Eligibility Criteria

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

Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII. MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.

You may qualify if:

  • ≥18 years of age.
  • Diagnosed of Type 1 Diabetes Mellitus.
  • Be attended in Ciudad Real General University Hospital.
  • Current treated with CSII (CSII cohort) or MDI (MDI cohort) during ≥6 months.

You may not qualify if:

  • Less than 18 years old.
  • Other types of diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obispo Rafael Torija, St.

Ciudad Real, 13005, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jesus Moreno-Fernandez, PhD

    Castilla-La Mancha Public Health Service.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 27, 2018

First Posted

January 4, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)