- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04723550
COVID-19 Lockdown Related Telemedicine for Type 2 Diabetes
23. januar 2021 opdateret af: Wenwen Yin
Impact of Telemedicine on Young and Middle-aged Obese Patients With Type 2 Diabetes Mellitus During COVID-19 Pandemic
At present, in order to cope with the global pandemic of the COVID-19 virus, governments have introduced corresponding measures, COVID-19 lockdown is one of the most important measures.
However, lockdown makes the management of chronic diseases (such as type 2 diabetes) more difficult, and telemedicine may be one of the solutions.
We hope to explore the effect of telemedicine on blood glucose control and other prognostic indicators of young and middle-aged obese patients with type 2 diabetes who will experience isolation control.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We recruit patients with type 2 diabetes who need to be isolated due to the COVID-19 epidemic, Our study will include young and middle-aged obese patients.
The lockdown period is 21 days.
The patients will be randomly divided into two groups with a total follow-up time of 6 months.
One group is the telemedicine intervention group, and the other group is the routine follow-up control group.
The intervention group used the hospital telemedicine management system to upload blood glucose values (fasting and 2h after three meals), food intake of three meals, and exercise volume (Data collection frequency: first three months, 4 times/week; 4-6 Month, 2 times/week).Doctors will collect data from hospital telemedicine management system to guide patients on diets, exercise, and medication adjustments.
The control group will be followed up by telephone/outpatient clinic every 1 week.
(only telephone follow-up will be conducted during the lockdown period) Then doctors will collect their blood glucose values.(fasting
and 2h after three meals) Based on the data collected, The doctors will provide lifestyle guidance to the patients on the telephone or face to face.
The clinical data of the two groups of patients will be collected at baseline, 22 days, 3 months, and 6 months respectively.
(HbA1c, fasting blood glucose(FBG), blood glucose 2 hours after breakfast, blood pressure, Body Mass Index(BMI), waist-to-hip ratio, total cholesterol(TC), triglyceride(TG), high-density lipoprotein cholesterol(HDL-C), low-density lipoprotein cholesterol(LDL-C), Blood Urea Nitrogen(BUN), serum creatinine(Scr), e-GFR, Self-rating Depression Scale, frequency of hypoglycemia,and Cost effectiveness) The clinical data will be statistically analyzed.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wenwen Yin, MD.
- Telefonnummer: +86 18112008016
- E-mail: wenwen261621@163.com
Undersøgelse Kontakt Backup
- Navn: Ning Ding, MD.
- Telefonnummer: +86 17712987026
- E-mail: 961897477@qq.com
Studiesteder
-
-
Jiangsu
-
Xuzhou, Jiangsu, Kina, 221000
- Rekruttering
- Department of Endocrinology, Xuzhou NO.1 Peoples Hospital
-
Kontakt:
- Wenwen Yin
- Telefonnummer: +86 18112008016
- E-mail: wenwen261621@163.com
-
-
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 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Physician diagnosis of Type 2 diabetes for more than 6 months
- 7.0%<HbA1c<10.0%
- Quarantine for 21 days due to COVID-19 outbreak related reasons
- age: 18 ~ 55 yrs
- BMI≥24
- Be able use smart phones and the Internet
Exclusion Criteria:
- Insulin pump users
- For female subjects: pregnancy or lactation, or subject may become pregnant during the study
- Patient who underwent obesity surgery to the exclusion of a gastric band, loosened or removed for more than a year
- Patients diagnosed with COVID-19 infection
- Have severe complications (chronic heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, chronic liver or kidney disease) that would affect the subjects' ability to follow the tailored advice
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Telemedicine
Diabetes education and support by telemedicine
|
Patients upload data of blood glucose, diet and exercise.
Then doctors guide patients' diet, exercise and medication adjustment through the telemedicine system.
|
Aktiv komparator: Usual care
Diabetes education and support in person
|
Outpatient/telephone follow-up:continued care, as usual, from their primary care provider through out duration of action 6 months intervention period
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Glucose control (HbA1c levels)
Tidsramme: Baseline, 22days,3 months and 6 months
|
Change in HbA1c among control and telemedicine groups from baseline to 6 months
|
Baseline, 22days,3 months and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in FBG
Tidsramme: Baseline, 22days,3 months and 6 months
|
Change in FBG among control and telemedicine groups from baseline to 6 months
|
Baseline, 22days,3 months and 6 months
|
Change in Blood glucose 2 hours after breakfast
Tidsramme: Baseline, 22days,3 months and 6 months
|
Change in Blood glucose 2 hours after breakfast among control and telemedicine groups from baseline to 6 months
|
Baseline, 22days,3 months and 6 months
|
Change in Blood pressure
Tidsramme: Baseline, 22days,3 months and 6 months
|
Change in Blood pressure among control and telemedicine groups from baseline to 6 months
|
Baseline, 22days,3 months and 6 months
|
Body mass BMI changes
Tidsramme: Baseline, 22days,3 months and 6 months
|
Comparison of BMI changes among control and telemedicine groups from baseline to 6 months
|
Baseline, 22days,3 months and 6 months
|
Change in waist-to-hip ratio
Tidsramme: 6 months
|
Comparison of waist-to-hip ratio changes among control and telemedicine groups from baseline to 6 months
|
6 months
|
Change in biological parameter: TC
Tidsramme: Baseline, 22days,3 months and 6 months
|
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC
|
Baseline, 22days,3 months and 6 months
|
Change in biological parameter: TG
Tidsramme: Baseline, 22days,3 months and 6 months
|
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG
|
Baseline, 22days,3 months and 6 months
|
Change in biological parameter: HDL-C
Tidsramme: Baseline, 22days,3 months and 6 months
|
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: HDL-C
|
Baseline, 22days,3 months and 6 months
|
Change in biological parameter: BUN
Tidsramme: Baseline, 22days,3 months and 6 months
|
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: BUN
|
Baseline, 22days,3 months and 6 months
|
Change in biological parameter: Scr
Tidsramme: Baseline, 22days,3 months and 6 months
|
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: Scr
|
Baseline, 22days,3 months and 6 months
|
Change in biological parameter: e-GFR
Tidsramme: Baseline, 22days,3 months and 6 months
|
Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: e-GFR
|
Baseline, 22days,3 months and 6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in scores measured by Self-rating Depression Scale
Tidsramme: Baseline, 22days,3 months and 6 months
|
Self-rating Depression Scale includes 20 items in four dimensions of psychological disorders, namely, psychotic emotional symptoms, somatic disorders, psychomotor disorders, and depression.
The maximum value of SDS is 50 points.
A lower total score means a better situation in terms of depression and vice versa
|
Baseline, 22days,3 months and 6 months
|
Number of hypoglycemia events
Tidsramme: 6 months
|
Hypoglycemia events for telemedicine group versus control group
|
6 months
|
Cost effectiveness
Tidsramme: 6 months
|
The objectives are to compare the results of the study in terms of cost and cost-effectiveness of these two strategies
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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)
5. januar 2021
Primær færdiggørelse (Forventet)
5. november 2021
Studieafslutning (Forventet)
5. januar 2022
Datoer for studieregistrering
Først indsendt
21. januar 2021
Først indsendt, der opfyldte QC-kriterier
21. januar 2021
Først opslået (Faktiske)
25. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungebetændelse, viral
- Lungebetændelse
- Lungesygdomme
- Sygdomme i det endokrine system
- COVID-19
- Diabetes mellitus
- Diabetes mellitus, type 2
Andre undersøgelses-id-numre
- NO.2020QN80
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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