Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

July 18, 2022 updated by: Castilla-La Mancha Health Service

Clinical Effects of Intermitent Continuous Glucose Monitoring (Flash) in Adult Patients With Type 1 Diabetes in an Spanish Public Health System

Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

All clinical variables are gathered from chart review. Data analysis is conducted using SPSS statistic software. Results are presented as mean +/- SD values. A paired Student´s t-test or Wilconxon signed test were used fr the analysis differences. Comparison between proportions were analyzed using a chi-square test. A P value <0.05 was considered statistically significant.

The protocolo was apporved by the reference Castilla-La Mancha Public Health Service Ethic Commitee. All participants provided written consent.

Study Type

Observational

Enrollment (Actual)

1121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Albacete University Hospital
      • Ciudad Real, Spain, 13005
        • Obispo Rafael Torija, St.
      • Guadalajara, Spain, 19002
        • Guadalajara University Hospital
      • Toledo, Spain, 45007
        • Toledo University Hospital
    • Ciudad Real
      • Alcázar De San Juan, Ciudad Real, Spain, 13600
        • La Mancha- Centro Hospital
      • Puertollano, Ciudad Real, Spain, 13500
        • Santa Barbara Hospital
      • Valdepeñas, Ciudad Real, Spain, 13300
        • Virgen de Altagracia Hospital
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Virgen del Prado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients >18 years with type 1 diabetes and previously followed in the DIACAM study (see reference).

Description

Inclusion Criteria:

  • Presence of Type 1 diabetes.
  • Age >18 years.
  • Patients previously followed in the DIACAM study.

Exclusion Criteria:

  • Any other kinds of diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult Type 1 Diabetes

All adult patients with type 1 diabetes previously followed in the DIACAM study (see bellow reference).

Sastre J, Pinés PJ, Moreno J, Aguirre M, Blanco B, Calderón D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003.
Device: Flash
Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.
Other Names:
  • FreeStyle Libre
  • iCGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c difference
Time Frame: 1 year
Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of SBGM
Time Frame: 1 year
Daily number of blood capilary test fot glycemia determination.
1 year
Adherence to Flash
Time Frame: 1 year
Time of use of Flash glucose monitoring (% possible time of use)
1 year
TIR
Time Frame: 1 year
Time in range (TIR, 3.9-10 mmol/L) of the interstitial glucose
1 year
TAR
Time Frame: 1 year
Time above range (TAR, >10 mmol/L) of the interstitial glucose
1 year
TBR
Time Frame: 1 year
Time bellow range (TBR, <3.9 mmol/L) of the interstitial glucose
1 year
%CV
Time Frame: 1 year
Percentage of the variation coefficient (%, >36% is considered high levels)
1 year
Body weight
Time Frame: 1 year
Total corporal body weight (Kg)
1 year
Insulin dose
Time Frame: 1 year
Daily insulin dose requirements (UI/Kg/d)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

May 6, 2022

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

After approval for the rest ot investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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