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Effects of the Insulin Self Titration Education for Type 2 Diabetes Mellitus Patients (ISTE)

11. februar 2021 opdateret af: Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

Effects of the Insulin Self-titration Education on Glycemic Control in Type 2 Diabetes Mellitus Patients: A Quasi-Experimental Study

The purpose of the study was to evaluate the effects of an insulin self-titration education program on glycemic control, self-efficacy, and self-care behaviors in patients with type 2 diabetes. The quasi-experimental design was adapted. A convenient sample of 120 patients with insulin-treated type 2 diabetes was recruited from a general hospital in Taiwan. Among them, 60 were in the insulin self-titration group, and 60 were in the comparison group. Data on glycated hemoglobin (HbA1C), self-efficacy, and self-care behavior were collected at baseline, three-month, and six-month follow-up. The study instruments included the Insulin Diabetes Management Self-Efficacy Questionnaire and Diabetes Self-Care questionnaire.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Sixty patients with insulin-treated type 2 diabetes were recruited as the intervention participants and enrolled in the insulin self-titration program. Sixty propensity score-matched patients treated with traditional insulin therapy without self-titration were recruited as the control participants. Data on HbA1C and hypoglycemia were collected at baseline and during follow-ups at three and six months. Data on self-efficacy and self-care were collected at the six-month follow-up using self-report questionnaires.

The inclusion criteria were recruited: (1) age ≥ 18 years; (2) diagnosis of type 2 diabetes; (3) treatment with insulin injection for > six months; (4) HbA1C > 7.5% in the last three months; and (5) ability to communicate in Mandarin or Taiwanese.

The insulin self-titration education program includes a 60-min small-group lesson, a 20-min individual instruction. Patients in the comparison group received usual care at the Diabetes Health Education Center. During a 15-min individual education, these patients were taught how to self-inject insulin and test and record their before-breakfast and before-dinner blood glucose levels daily at home Data on glycated hemoglobin (HbA1C) and the number of hypoglycemia were collected at baseline, three-month, and six-month follow-up. Data on self-efficacy and self-care were collected at the six-month follow-up, using the self-reported questionnaires. The study was approved by the institutional review board of the hospital where the data were collected.

Data were analyzed by using the SPSS 21.0 software. Descriptive analyses were used to describe the research variables. Chi-Square and independent t-test were used to analyze the baseline equilibriums between the two groups. Independent t-tests were used to analyze between-group differences in HbA1C at each time point. A generalized estimating equation (GEE) was used to analyze between-group differences in HbA1C change over time. The independent t-test was used to analyze the difference between the two groups of participants in the post-testing diabetes self-efficacy and self-care.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age ≥ 18 years
  • diagnosis of type 2 diabetes
  • treatment with insulin injection for > six months
  • HbA1C > 7.5% in the last three months
  • ability to communicate in Mandarin or Taiwanese

Exclusion Criteria:

  • non

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ISTE Group
This program includes a 60-min small-group lesson, a 20-min individual instruction. The education program's goal is to teach patients to self-titrate their insulin doses every six days to maintain their six-day average blood glucose levels < 120 mg/dl
Andet: Insulin Self-Titration Education Program
The program contents of instruction included blood glucose self-monitoring, types of insulin, insulin self-administration, insulin dose titration, hyperglycemia or hypoglycemia self-management, diet, and exercise.a 20-min one-on-one training session from a nurse on how to self-titrate the insulin dose. The participants were taught to monitor their before-breakfast and before-dinner blood glucose levels at home and adjust their insulin doses accordingly.
Placebo komparator: Non-ISTE Group
The usual care (a 15-min individual education) was giving at the Diabetes Health Education Center. They were taught how to self-inject insulin and test and record their before-breakfast and before-dinner blood glucose levels daily at home.
Andet: Insulin Self-Titration Education Program
The program contents of instruction included blood glucose self-monitoring, types of insulin, insulin self-administration, insulin dose titration, hyperglycemia or hypoglycemia self-management, diet, and exercise.a 20-min one-on-one training session from a nurse on how to self-titrate the insulin dose. The participants were taught to monitor their before-breakfast and before-dinner blood glucose levels at home and adjust their insulin doses accordingly.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1C
Tidsramme: six-month follow-up
HbA1c was measured by a 3cc venous blood sample was and analyzed with the Tosoh G8 HPLC Analyzer.
six-month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
self-efficacy
Tidsramme: six-month follow-up
The Chinese version of the Insulin Management Diabetes Self-Efficacy Scale (IMDSES) was used to assess a participant's degree of confidence in the ability of self-controlled diabetes. The 28-item scale includes six subscales: general self-efficacy, dietary self-efficacy, insulin self-efficacy, blood glucose monitoring self-efficacy, exercise self-efficacy, and foot self-efficacy. Each item is rated on a scale from 0 (completely unsure) to 100 (very sure). The average score of all items represents the scale sore, with a possible range of 0 to 100. The higher the score the better the self-efficacy. In this study, the Cronbach's α of this scale was 0.89, and the Cronbach's α value of each sub-scale was between 0.69 and 0.95.
six-month follow-up
self-care behavior
Tidsramme: six-month follow-up
The Chinese version of the revised Diabetes Self-Care Scale (DSC) was used to measure a participant's self-care behavior. The 28-item scale includes six subscales: general self-care, self-care for diet, self-care for insulin adjustment, self-care for blood glucose monitoring, self-care for exercise, and self-care for the feet. Each item is rated on a scale from 0 (not done at all) to 100 (completely done). The average score of all items represents the scale score, with a possible range of 0 to 100. The higher the score the better the self-care behavior. In this study, the Cronbach's α of this scale was 0.89, and the Cronbach's α value of each subscale was between 0.69 and 0.86.
six-month follow-up

Samarbejdspartnere og efterforskere

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

Sponsor

National Taipei University of Nursing and Health Sciences

Samarbejdspartnere

Chiayi Christian Hospital

Efterforskere

  • Ledende efterforsker: Tsae-Jyy Wang, National Taipei University of Nursing and Health Science

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)

1. juni 2010

Primær færdiggørelse (Faktiske)

30. juli 2011

Studieafslutning (Faktiske)

30. juli 2011

Datoer for studieregistrering

Først indsendt

29. januar 2021

Først indsendt, der opfyldte QC-kriterier

29. januar 2021

Først opslået (Faktiske)

3. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCYCH-099034

Plan for individuelle deltagerdata (IPD)

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INGEN

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Kliniske forsøg med Type 2 diabetes

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