NCT05095610

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,121

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

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

First Submitted

Initial submission to the registry

September 30, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

September 30, 2021

Last Update Submit

July 18, 2022

Conditions

Type 1 Diabetes

Keywords

type 1 diabetesintermitent continous glucose monitoringFlash

Outcome Measures

Primary Outcomes (1)

  • HbA1c difference

    Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment.

    1 year

Secondary Outcomes (8)

  • Frequency of SBGM

    1 year

  • Adherence to Flash

    1 year

  • TIR

    1 year

  • TAR

    1 year

  • TBR

    1 year

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

FlashDEVICE

Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.

Also known as: FreeStyle Libre, iCGM
Adult Type 1 Diabetes

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Any other kinds of diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

La Mancha- Centro Hospital

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Santa Barbara Hospital

Puertollano, Ciudad Real, 13500, Spain

Location

Virgen de Altagracia Hospital

Valdepeñas, Ciudad Real, 13300, Spain

Location

Virgen del Prado Hospital

Talavera de la Reina, Toledo, 45600, Spain

Location

Albacete University Hospital

Albacete, 02006, Spain

Location

Obispo Rafael Torija, St.

Ciudad Real, 13005, Spain

Location

Guadalajara University Hospital

Guadalajara, 19002, Spain

Location

Toledo University Hospital

Toledo, 45007, Spain

Location

Related Publications (2)

  • Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon 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. Epub 2012 Oct 4. English, Spanish.

    PMID: 23039989BACKGROUND

  • Moreno-Fernandez J, Sastre J, Pines P, Calderon-Vicente D, Gargallo J, Munoz-Rodriguez JR. To evaluate the use and clinical effect of intermittently scanned continuous glucose monitoring in adults with type 1 diabetes: Results of a multicentre study. Endocrinol Diabetes Nutr (Engl Ed). 2023 Apr;70(4):270-276. doi: 10.1016/j.endien.2023.03.013.

    PMID: 37116972DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1photopsia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 27, 2021

Study Start

November 1, 2021

Primary Completion

March 30, 2022

Study Completion

May 6, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

ES(8)