Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

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: Type 1 Diabetes
• Intervention / Treatment: Device: Flash

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

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

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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

Collaborators and Investigators

• Sponsor: Castilla-La Mancha Health Service

Publications and helpful links

General Publications

• 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.

Study record dates

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: type 1 diabetes; Flash; intermitent continous glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• 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