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Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus (Education)

21. marts 2019 opdateret af: Jae Hyeon Kim, Samsung Medical Center

Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus

Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved and highly recommended in the treatment of type 1 diabetes patients worldwide, and related technology development and market are growing rapidly.

In order to maximize the medical and socioeconomic effects of the latest blood glucose devices including CGM and insulin pump, structured education is necessary. In this study, we will develop patient-oriented structured education for patients with type 1 diabetes mellitus when applying CGM, and we will assess the efficacy of this education protocol for patients with type 1 diabetes using CGM.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose level is not well controlled, and who are undergoing multiple daily insulin injection therapy or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal continuous glucose levels for 1 week (window period of 2 week).

These 50 patients are 1:1 randomly assigned to 2 groups including control group and intervention group. Control group (n=25) applied CGM without structured education and after 3 months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected. As a sequential extension clinical trial, those 25 patients in control group are provided structured education, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected.

In Intervention group (n=25), structured education program is provided for each patient from the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Over 18 years old - under 70 years old patients with Type 1 diabetes
  • Those who plan to use CGM G5
  • Patients who consented to use CGM G5 in conjunction with Clarity
  • Those who are using multiple insulin injections or insulin pumps for at least 3 months
  • Those whose fasting c-peptide <0.6 ng / dL, or stimulated c-peptide <1.8 ng / dL
  • Those with a glycated hemoglobin of 7.0% or more within the last 3 months
  • Those who have never used a CGM for more than a month
  • For women of childbearing age, those who agree to use appropriate contraception during the trial
  • Those who voluntarily signed the agreement after the explanation of the clinical trial

Exclusion Criteria:

  • Those with a history of severe hypoglycemia and acute ketoacidosis within the last 3 months
  • Patients with chronic renal function greater than or equal to stage 4 (estimated glomerular filtration rate [assessed by MDRD (modification of diet in renal disease] <30 )
  • Patients with acute myocardial infarction, unstable angina, coronary artery disease or stroke within the last 3 months
  • Patients with adrenal insufficiency, pituitary dysfunction, medically uncontrolled hyperthyroidism or hypothyroidism
  • Those taking medications that can affect the glucose metabolism (eg, corticosteroids, immunostimulants, etc.)
  • Pregnant and lactating women
  • A person who is deemed unsuitable for participation in clinical trials by examiners

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Control
Without structured education when applying CGM for 3months, and as a sequential extension clinical trial, after 3 months, structured education is provided, followed by CGM apply
Adfærdsmæssigt: Structured Education for new glucose management devices
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
Aktiv komparator: Intervention
provide structured education when applying CGM for 3 months
Adfærdsmæssigt: Structured Education for new glucose management devices
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of time in target range 70-180 mg/dL
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of time in level 2 hypoglycemia (<54mg/dL)
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hyperglycemia (>180mg/dL)
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 2 hyperglycemia (>250mg/dL)
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as coefficient of variance (CV)
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as standard deviation (SD)
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
Mean glucose by continuous glucose monitoring system
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Mean glucose by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
HbA1C
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
HbA1C
3months (control and intervention groups) and 6months (for extension study in control group)
glycated albumin
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
glycated albumin
3months (control and intervention groups) and 6months (for extension study in control group)
Personalized education time for each patient
Tidsramme: baseline (intervention group) and 3months (for extension study in control group)
Personalized education time for each patient
baseline (intervention group) and 3months (for extension study in control group)
Frequency of hypoglycemia
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Frequency of hypoglycemia
3months (control and intervention groups) and 6months (for extension study in control group)
Adverse event
Tidsramme: 3months (control and intervention groups) and 6months (for extension study in control group)
Adverse event occurred
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL
Tidsramme: 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
6months (for extension study in control group)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samsung Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. februar 2019

Primær færdiggørelse (Forventet)

31. december 2019

Studieafslutning (Forventet)

31. december 2020

Datoer for studieregistrering

Først indsendt

4. januar 2019

Først indsendt, der opfyldte QC-kriterier

4. januar 2019

Først opslået (Faktiske)

7. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2018-12-108

Plan for individuelle deltagerdata (IPD)

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