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Type 1 DiabetesNCT05570162

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

A study testing Diabetes educational program in people with Type 1 Diabetes, run by Castilla-La Mancha Health Service at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Diabetes educational program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteSpain
Study dates
1 Nov 2022to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Ciudad Real General University Hospital

    Ciudad Real, 13005

Other trials in Spain

About this study

Official title: Clinical Efficacy of a Diabetes Educational Program to Improve Intermittently Continuous Glucose Monitoring (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

Read the detailed description

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).

Conditions
Type 1 Diabetes
Being tested
Diabetes educational program
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes educational programOther

    30-minute long diabetes educational program

Study groups in NCT05570162
Study groupRoleWhat they receive
Low Flash adherenceExperimentalAdult (>18 yrs old) type 1 diabetes patients with 4 or less daily Flash scans
Receives: Other: Diabetes educational program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to Flash 1

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

    Measured: 14 days

Secondary outcomes (11)

  1. Time in range

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

    Measured: 14 days

  2. Adherence to Flash 2

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

    Measured: 14 days

  3. Time below range 1 (TBR1)

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

    Measured: 14 days

  4. Time below range 2 (TBR2)

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

    Measured: 14 days

  5. Time above range 1 (TAR1)

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

    Measured: 14 days

  6. Time above range 2 (TAR2)

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

    Measured: 14 days

  7. Coefficient of variation percentage (CV)

    Coefficient of variation percentage of interstitial glucose

    Measured: 14 days

  8. Glucose management index

    Glucose management index of interstitial glucose

    Measured: 14 days

  9. Time in hypoglycemia

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

    Measured: 14 days

  10. Hypoglycemia frequency

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

    Measured: 14 days

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

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

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start1 Nov 2022
  3. Primary completion30 Sep 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
30 minutes diabetes educational program: * 10-minute talk about Flash measurements and importance of diabetes control. * 10-minute practic exercises with Flash values and tendencies. * 10-minute talk about recomendations for increasing daily Flash scanning.
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05570162
Sponsor's protocol ID
C-558
Status last verified
Nov 2023
First submitted
4 Oct 2022
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Under other researchers request.

Publications

  • Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018 Feb;6(2):130-142. doi: 10.1016/S2213-8587(17)30239-5. Epub 2017 Sep 29.

    PubMed 28970034

  • Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.

    PubMed 30844467

  • Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.

    PubMed 27634581

  • Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24.

    PubMed 29278709

  • Gomez-Peralta F, Dunn T, Landuyt K, Xu Y, Merino-Torres JF. Flash glucose monitoring reduces glycemic variability and hypoglycemia: real-world data from Spain. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e001052. doi: 10.1136/bmjdrc-2019-001052.

    PubMed 32198165

  • Pazos-Couselo M, Izquierdo V, Martinez MM, Romero FJG, Munoz-Rodriguez JR, Fernandez-Pombo A, Moreno-Fernandez J. A Nurse-Led Educational Intervention for Patients With Type 1 Diabetes Using Continuous Glucose Monitoring. Worldviews Evid Based Nurs. 2026 Apr;23(2):e70139. doi: 10.1111/wvn.70139.

    PubMed 41968908

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes educational program in people with Type 1 Diabetes, run by Castilla-La Mancha Health Service at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to Flash 1 (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05570162, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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