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Menstruationscyklus kortlægning ved brug af lukket-løkke insulinadministrering (MCM-Loop)

28. maj 2026 opdateret af: Lia Bally

Menstruationscyklusmapping ved brug af lukket sløjfe-insulinadministration

Hypotesen er, at menstruationscyklusens periodicitet påvirker glukose- og energistofskiftet hos kvinder med type 1-diabetes. Begrundelsen for hypotesen om cykluseffekter bygger på antagelsen om, at udsving i kvindelige kønshormoner gennem menstruationscyklussen forårsager ændringer i fysiologiske parametre for glukosestofskifte og energihomeostase og/eller livsstilsaspekter involveret i reguleringen af blodsukker og kropsvægt. Det forventes, at hormonudsving påvirker insulinfølsomhed, mavetømning, spiseadfærd og energiomsætning. Det forventes, at insulinfølsomheden er højest i den preovulatoriske fase og lavest i midlutealfasen. Det forventes yderligere, at mavetømningen topper i folikelfasen, og højest energiomsætning og kostindtag i midlutealfasen.

Det primære formål med denne undersøgelse er at karakterisere glukose- og energistofskiftet gennem hele menstruationscyklussen hos naturligt cyklende kvinder med type 1-diabetes. Yderligere formål er at vurdere menstruationscyklusens indflydelse på glukosekontrol og insulinbehov, undersøge, hvordan udsving i kønshormonniveau påvirker glukose- og energistofskiftet, og kvantificere både inter- og intraindividuel variation i metabolske ændringer relateret til menstruationscyklussen. Desuden vil undersøgelsen evaluere, om ændringer i nøglefysiologiske komponenter af glukosestofskiftet og adfærdsfaktorer medierer menstruationscyklusrelaterede variationer i glukosekontrol og insulinbehov.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

Kontakter og lokationer

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

Studiesteder

  • Schweiz
    • Canton of Bern
      • Bern, Canton of Bern, Schweiz, 3010
        • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital

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

  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Berettigede deltagere vil være kvinder i alderen 18-45 år, med en naturlig menstruationscyklus (der forekommer uden medicinsk eller hormonel intervention), som har type 1-diabetes og er villige til at følge studie-relaterede procedurer.

Beskrivelse

Inklusionskriterier:

  • Kvindeligt køn tildelt ved fødslen
  • Type 1-diabetes i mindst 12 måneder
  • Alder 18-45 år
  • Naturlig menstruationscyklus (forekommer uden medicinske eller hormonelle indgreb)
  • Funktionel insulinbehandling leveret via injektion eller insulinpumpe
  • Villighed til at følge studie-relaterede procedurer
  • Villighed til at bruge mekanisk prævention i løbet af studiedeltagelsen

Eksklusionskriterier:

  • Brug af præventionsmidler eller medicinske indgreb, der forstyrrer de naturlige hormonelle udsving i menstruationscyklussen eller cyklisk blødning
  • Indgreb, der forstyrrer glukose- eller energistofskiftet (bortset fra insulin, skjoldbruskkirtelhormon-erstatning eller statiner), som vurderet af undersøgeren, vil blive sat på pause i studietiden, med en tilstrækkelig washout-periode før starten af dataindsamlingen
  • Tilstedeværelse af enhver fysisk eller psykisk tilstand, eller ethvert medicinsk indgreb, der sandsynligvis vil forstyrre gennemførelsen af procedurerne og/eller deres evaluering, som vurderet af undersøgeren
  • Gravid eller ammende
  • Deltagelse i et andet klinisk studie, der forstyrrer fortolkningen af studieresultaterne, som vurderet af undersøgeren

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Women with Type 1 Diabetes
Participants with type 1 diabetes from age 18 to 45 years and a natural menstrual cycle will be followed for 3 consecutive menstrual cycles.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time in target glucose range
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

The primary metric for glucose control is the proportion of time with sensor glucose levels in the target range (3.9-10mmol/L, %).

Glucose levels will be measured using a continuous glucose monitoring sensor (Dexcom G6 or an equivalent CGM sensor).
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Substratoxidation
Tidsramme: Vurderet én gang ved hver fase-specifik vurdering (tidlig follikulær, pre-ovulatorisk og luteal) for én menstruationscyklus
Substratoxidation (dvs. kvantificeret ved den relative bidrag af fedtforbrænding til hvilestofskiftet) vil blive målt ved indirekte kalorimetri i fastende tilstand (≥8 timer) for at give yderligere kontekst som en fysiologisk determinant for glukose- og energistofskifte. Dette udfald måles kun i en undergruppe på 15 deltagere.
Vurderet én gang ved hver fase-specifik vurdering (tidlig follikulær, pre-ovulatorisk og luteal) for én menstruationscyklus
Algorithm-directed insulin delivery following a standardized meal
Tidsramme: The outcome will be measured at each standardized meal assessment, performed during the three key menstrual cycle phases (early-follicular, pre-ovulatory, and mid-luteal),across three menstrual cycles, resulting in a total of nine 3-hour assessment times
The primary insulin metric is the algorithm-directed insulin dose (units) delivered over a 3 hour period following a standardized meal without a manual bolus. Insulin delivery is recorded using the mylife CamAPS FX automated insulin delivery system.
The outcome will be measured at each standardized meal assessment, performed during the three key menstrual cycle phases (early-follicular, pre-ovulatory, and mid-luteal),across three menstrual cycles, resulting in a total of nine 3-hour assessment times
Insulin sensitivity
Tidsramme: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Insulin sensitivity will be estimated continuously throughout the study from sensor glucose and insulin pump data, collected via the mylife CamAPS FX automated insulin delivery system, using mathematical modeling.
Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Gastric emptying
Tidsramme: The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.

This outcome is based in the [13C]-acetate breath test. Breath 13CO2 enrichment is analyzed using infrared spectrometry and kinetics parameters are derived using mathematical modelling. The main parameter of interest is T50 (ie., the time until half of the ingested meal was absorbed).

This outcome is measured only in a subgroup of 15 participants.
The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.
Total energy expenditure
Tidsramme: Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
Total energy expenditure will be quantified using the doubly labelled water method. This outcome is measured only in a subgroup of 15 participants.
Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
Dietary intake
Tidsramme: Measured for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days over 3 cycles
Total energy intake (kcal/day) will be assessed by recording all meals using an image-based automated food analysis application SNAQ.
Measured for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days over 3 cycles
Physical activity
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
The number of steps per day, as a component of physical activity, will be measured using the Garmin Venu 3 smartwatch.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hvileenergiforbrug
Tidsramme: Vurderet én gang ved hver fasespecifik vurdering (tidlig follikulær, før ægløsning og luteal) i én menstruationscyklus.
Hvileenergiforbrug (kcal/dag) måles ved indirekte kalorimetri i fastetilstand (≥8 timer) for at give yderligere kontekst som en fysiologisk determinant for energimetabolisme.
Dette udfald måles kun i en undergruppe på 15 deltagere.
Vurderet én gang ved hver fasespecifik vurdering (tidlig follikulær, før ægløsning og luteal) i én menstruationscyklus.
Patientrapporteret opfattet indvirkning
Tidsramme: Ved studiafslutning (efter tre menstruationscykler).
Den opfattede indflydelse af menstruationscyklus på diabeteskontrol og -håndtering vil blive indsamlet retrospektivt ved studiet afslutning ved hjælp af et oplevelses-spørgeskema.
Ved studiafslutning (efter tre menstruationscykler).
Postprandial mean glucose
Tidsramme: The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as at each standardized meal assessment, resulting in a total of nine 3-hour assessment times.
Mean postprandial glucose levels measured using continuous glucose monitoring in the 3 hours following meals. Meal timepoints defined as manual carbohydrate entries in the mylife CamAPS FX automated insulin delivery system. This outcome serves as an additional metric within the overall assessment of glucose control. Additionally, mean postprandial glucose levels will be specifically measured in the 3 hours following the standardized meal assessment using continuous glucose monitoring.
The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as at each standardized meal assessment, resulting in a total of nine 3-hour assessment times.
Postprandial peak glucose
Tidsramme: The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as once for each standardized meal assessment (9 values in total).
Peak postprandial glucose levels measured using continuous glucose monitoring in the 3 hours following meals. Meal timepoints defined as manual carbohydrate entries in the mylife CamAPS FX automated insulin delivery system. This outcome serves as an additional metric within the overall assessment of glucose control. Additionally, peak postprandial glucose levels will be specifically measuredin the 3 hours following the standardized meal assessment using continuous glucose monitoring.
The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as once for each standardized meal assessment (9 values in total).
Proportion of time spent in the hyperglycaemic range
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles)

Glucose levels above 10 mmol/L are classified as hyperglycaemic. Glucose levels will be measured using a continuous glucose monitoring (Dexcom G6 system or an equivalent CGM sensor).

This outcome serves as an additional metric within the overall assessment of glucose control.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles)
Proportion of time spent in hypoglycaemic range
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Glucose levels below 3.9 mmol/L are classified as hypoglycaemic. Glucose levels will be measured using continuous glucose monitoring (Dexcom G6 system or an equivalent CGM sensor) This outcome serves as an additional metric within the overall assessment of glucose control.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Glucose variability - standard deviation
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

Glucose variability assessed as the standard deviation (SD) of sensor glucose values measured using continuous glucose monitoring.

This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Glucose variability - coefficient of variation
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

Glucose variability assessed as the coefficient of variation (CV) of sensor glucose values measured using continuous glucose monitoring data.

This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Glucose variability - mean amplitude of glycaemic excursions
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

Glucose variability assessed as the mean amplitude of glycaemic excursions (MAGE) derived from continuous glucose monitoring data.

This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Total daily insulin dose
Tidsramme: Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Total daily insulin dose (U/day) will be evaluated using the mylife CamAPS FX automated insulin delivery system, which includes a continuous glucose monitoring sensor (Dexcom G6 or an equivalent CGM sensor for participants already using mylife CamAPS FX with a different sensor), an insulin pump (YpsoPump), and the CamAPS FX application. This outcome serves as an additional measure of individual insulin requirements.
Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Basal insulin
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

As an additional measure of insulin requirements, the proportion of basal insulin relative to total insulin delivery (%) will be assessed.

It will be measured using the mylife CamAPS FX AID system consisting of a continuous glucose monitoring sensor (Dexcom G6 system or an equivalent CGM sensor if they already use the mylife CamAPS FX AID system with a different sensor), the insuline pump (Ypsopump) and the CamAPS FX app.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Bolus frequency
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Units are (n/day). The outcome is the number of manual boluses entered into the mylife CamAPS FX AID system.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Model-estimated energy intake
Tidsramme: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Daily energy intake (kcal/day) will be estimated using an energy balance model based on frequently measured body weight and physical activity data, and, where available, energy expenditure assessed using the doubly labeled water methodology. This outcome provides a complementary, model-based estimate of energy intake alongside self-reported dietary intake.
Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Proportion of carbohydrate intake
Tidsramme: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
The proportion of carbohydrate intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
Proportion of fat intake
Tidsramme: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
The proportion of fat intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
Proportion of protein intake
Tidsramme: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
The proportion of protein intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
Dietary fiber intake
Tidsramme: Total intake over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
Dietary fiber intake will be derived from meal records collected using the SNAQ application as an additional component of overall dietary intake assessment.
Total intake over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
Food category distribution
Tidsramme: Measured continuously at every meal for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
Food category distribution will be derived from meal records collected using the SNAQ application, providing complementary information on dietary patterns within overall dietary intake.
Measured continuously at every meal for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
Activity minutes per day
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Active minutes per day will be measured using the Garmin Venu 3 smartwatch as a complementary indicator of physical activity.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Body weight
Tidsramme: Measured daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Body weight will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
Measured daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Fat mass
Tidsramme: Daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Percentage of body fat mass, as a component of body composition, will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
Daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Fat-free mass
Tidsramme: Measured daily over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Percentage of fat-free mass, as a component of body composition, will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
Measured daily over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Beta-hydroxybutyrate levels
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Beta-hydroxybutyrate levels (mmol/L), will be assessed using the SiBio Ketone Sensor to provide additional metabolic context.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Heart rate
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Heart rate (bpm), will be assessed using the Garmin Venu 3 smartwatch to provide a broader metabolic context.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Heart rate variability
Tidsramme: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Heart rate variability (High and low frequency components or equivalent time domain indices), will be assessed using the Garmin Venu 3 smartwatch to provide a broader metabolic context and as an indicator of autonomic nervous system activity.
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Patient-reported perceived impact - real-time electronic logs
Tidsramme: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
Perceived impact of the menstrual cycle on diabetes control and management will be captured additionally in real time using electronic logs in a smartphone app. Data are considered supplementary to the experience questionnaire-based assessment.
Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).

Samarbejdspartnere og efterforskere

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

Sponsor

Lia Bally

Samarbejdspartnere

University of Bern
DexCom, Inc.
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Innosuisse - Swiss Innovation Agency
Insel Gruppe AG, University Hospital Bern
mylife Diabetes Care AG
Gertrud and Walter Siegenthaler Foundation
Burgergemeinde
Bangerter Foundation and Swiss Academy of Medical Science
Fresenius Kabi (Schweiz) AG
Bern Medtech Collaboration Call

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)

9. maj 2025

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

22. december 2025

Først indsendt, der opfyldte QC-kriterier

12. marts 2026

Først opslået (Faktiske)

17. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MCM-Loop

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individuelle deltagerdata (IPD) vil blive stillet til rådighed ved rimelig anmodning til hovedforskeren.

IPD-delingstidsramme

IPD vil være tilgængelig fra 12 måneder efter offentliggørelsen af forsøgsresultaterne.

IPD-delingsadgangskriterier

Ekspeditionsgodkendelse, som det er relevant i henhold til schweizisk lovgivning, skal indhentes af dem, der anmoder om dataene. Derudover skal der være en dataoverførsels- og behandlingsaftale på plads for at sikre overholdelse af databeskyttelsesreglerne.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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