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NCT Number: NCT05095610

Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases photopsia

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

La Mancha- Centro Hospital, Alcázar de San Juan, Ciudad Real, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any other kinds of diabetes.

Treatment and study plan

Flash

Device

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

Other names: FreeStyle Libre, iCGM

Primary outcomes

  1. HbA1c difference

    Time frame: 1 year

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

Secondary outcomes

  1. Frequency of SBGM

    Time frame: 1 year

    Daily number of blood capilary test fot glycemia determination.

  2. Adherence to Flash

    Time frame: 1 year

    Time of use of Flash glucose monitoring (% possible time of use)

  3. TIR

    Time frame: 1 year

    Time in range (TIR, 3.9-10 mmol/L) of the interstitial glucose

  4. TAR

    Time frame: 1 year

    Time above range (TAR, >10 mmol/L) of the interstitial glucose

  5. TBR

    Time frame: 1 year

    Time bellow range (TBR, <3.9 mmol/L) of the interstitial glucose

  6. %CV

    Time frame: 1 year

    Percentage of the variation coefficient (%, >36% is considered high levels)

  7. Body weight

    Time frame: 1 year

    Total corporal body weight (Kg)

  8. Insulin dose

    Time frame: 1 year

    Daily insulin dose requirements (UI/Kg/d)

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2021
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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