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NCT Number: NCT05570162

Clinical Efficacy of a Diabetes Educational Program to Improve Flash Adherence in Type 1 Diabetes Patients

Prospective observational study to analyse the clinical effectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients

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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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ciudad Real General University Hospital

Ciudad Real, 13005, Spain

About this study

Cross-sectional prospective analysis of clinical efectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients. Glycometric data obtained through deidentified downloads from isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant. The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee (C-558).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes
  • Flash user for at least 6 months.
  • Treatment with multiple daily insulin injections (MDI).
  • Daily scan Flash frequency 4 or less

Exclusion criteria

  • Other types of diabetes
  • Other types of diabetes treatment different from MDI (pe insulin pump)

Treatment and study plan

Diabetes educational program

Other

30-minute long diabetes educational program

Primary outcomes

  1. Adherence to Flash 1

    Time frame: 14 days

    Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)

Secondary outcomes

  1. Time in range

    Time frame: 14 days

    Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose

  2. Adherence to Flash 2

    Time frame: 14 days

    Time of use of intermittently scanned continuous glucose monitoring (% possible time of use)

  3. Time below range 1 (TBR1)

    Time frame: 14 days

    Time bellow range <3.9 mmol/L (<70 mg/dL) of the interstitial glucose

  4. Time below range 2 (TBR2)

    Time frame: 14 days

    Time bellow range <3 mmol/L (<54 mg/dL) of the interstitial glucose

  5. Time above range 1 (TAR1)

    Time frame: 14 days

    Time above range >10 mmol/L(>180 mg/dL) of the interstitial glucose

  6. Time above range 2 (TAR2)

    Time frame: 14 days

    Time above range >13.9 mmol/L (>250 mg/dL) of the interstitial glucose

  7. Coefficient of variation percentage (CV)

    Time frame: 14 days

    Coefficient of variation percentage of interstitial glucose

  8. Glucose management index

    Time frame: 14 days

    Glucose management index of interstitial glucose

  9. Time in hypoglycemia

    Time frame: 14 days

    Daily time in hypoglycemia (<3.9 mmol/L, <70 mg/dL) of interstitical glucose

  10. Hypoglycemia frequency

    Time frame: 14 days

    Number of daily hypoglycemic events (<3.9 mmol/L, <70 mg/dL) of interstitical glucose

  11. Percentage of patients attaining the the International Consensus on Time in Range (ICTR)

    Time frame: 14 days

    Percentage of patients (from total) attaining TIR>70%, TBR1<4%, TBR2<1%, TAR1<25%, TAR2<5% and CV <36%

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Registry information

Official study title

Clinical Efficacy of a Diabetes Educational Program to Improve Intermittently Continuous Glucose Monitoring (Flash) Adherence in Type 1 Diabetes Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Nov 13, 2023

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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