NCT05570162

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

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

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

October 4, 2022

Last Update Submit

November 10, 2023

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Adherence to Flash 1

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

    14 days

Secondary Outcomes (11)

  • Time in range

    14 days

  • Adherence to Flash 2

    14 days

  • Time below range 1 (TBR1)

    14 days

  • Time below range 2 (TBR2)

    14 days

  • Time above range 1 (TAR1)

    14 days

  • +6 more secondary outcomes

Study Arms (1)

Low Flash adherence

EXPERIMENTAL

Adult (\>18 yrs old) type 1 diabetes patients with 4 or less daily Flash scans

Other: Diabetes educational program

Interventions

Diabetes educational programOTHER

30-minute long diabetes educational program

Low Flash adherence

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ciudad Real General University Hospital

Ciudad Real, 13005, Spain

Location

Related Publications (5)

  • 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.

    PMID: 28970034RESULT

  • 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.

    PMID: 30844467RESULT

  • 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.

    PMID: 27634581RESULT

  • 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.

    PMID: 29278709RESULT

  • 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.

    PMID: 32198165RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jesus Moreno-Fernandez, PhD

    Ciudad Real General University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

November 1, 2022

Primary Completion

September 30, 2023

Study Completion

October 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Under other researchers request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will become available after 1 month of the request and for a 3-month period.
Access Criteria
After request study from IP and ethic comittee.

Locations

ES(1)