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Menstruationszyklus-Kartierung bei Verwendung eines Closed-Loop-Insulinabgabesystems (MCM-Loop)

11. September 2026 aktualisiert von: Lia Bally

Menstruationszyklus-Kartierung bei Verwendung einer Closed-Loop-Insulinabgabe

Die Hypothese besagt, dass die Menstruationszyklizität den Glukose- und Energiestoffwechsel bei Frauen mit Typ-1-Diabetes beeinflusst. Die Begründung der Hypothese zu Zykluseffekten basiert auf der Annahme, dass Schwankungen der weiblichen Geschlechtshormone während des Menstruationszyklus Veränderungen in physiologischen Parametern des Glukosestoffwechsels und der Energiehomöostase und/oder Lebensstilaspekten verursachen, die an der Regulation des Blutzuckerspiegels und Körpergewichts beteiligt sind. Es wird erwartet, dass Hormonschwankungen die Insulinsensitivität, die Magenentleerung, das Essverhalten und den Energieverbrauch beeinflussen. Es wird angenommen, dass die Insulinsensitivität in der präovulatorischen Phase am höchsten und in der mittleren Lutealphase am niedrigsten ist. Weiterhin wird erwartet, dass die Magenentleerung in der Follikelphase ihren Höhepunkt erreicht und der höchste Energieverbrauch und Nahrungsaufnahme während der mittleren Lutealphase auftreten.

Das primäre Ziel dieser Studie ist es, den Glukose- und Energiestoffwechsel während des gesamten Menstruationszyklus bei natürlich menstruierenden Frauen mit Typ-1-Diabetes zu charakterisieren. Weitere Ziele sind die Bewertung der Auswirkungen des Menstruationszyklus auf die Glukosekontrolle und den Insulinbedarf, die Untersuchung, wie Schwankungen der Geschlechtshormonspiegel den Glukose- und Energiestoffwechsel beeinflussen, und die Quantifizierung sowohl der inter- als auch intraindividuellen Variabilität der mit dem Menstruationszyklus verbundenen Stoffwechselveränderungen. Darüber hinaus wird die Studie bewerten, ob Veränderungen in Schlüsselkomponenten des Glukosestoffwechsels und Verhaltensfaktoren die mit dem Menstruationszyklus verbundenen Variationen in der Glukosekontrolle und dem Insulinbedarf vermitteln.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

40

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Teilnahmeberechtigt sind Frauen im Alter von 18 bis 45 Jahren mit einem natürlichen Menstruationszyklus (der ohne medizinische oder hormonelle Eingriffe auftritt), die an Typ-1-Diabetes erkrankt sind und bereit sind, die studienbezogenen Verfahren einzuhalten.

Beschreibung

Einschlusskriterien:

  • Weibliches Geschlecht bei der Geburt zugewiesen
  • Typ-1-Diabetes seit mindestens 12 Monaten
  • Alter 18-45 Jahre
  • Natürlicher Menstruationszyklus (ohne medizinische oder hormonelle Eingriffe)
  • Funktionelle Insulintherapie per Injektion oder Insulinpumpe
  • Bereitschaft, studienbezogene Verfahren zu befolgen
  • Bereitschaft, während der Studienteilnahme mechanische Verhütungsmittel zu verwenden

Ausschlusskriterien:

  • Verwendung von Verhütungsmitteln oder medizinischen Eingriffen, die die natürlichen hormonellen Schwankungen des Menstruationszyklus oder die zyklische Blutung beeinträchtigen
  • Eingriffe, die den Glukose- oder Energiestoffwechsel beeinflussen (außer Insulin, Schilddrüsenhormonersatz oder Statinen), werden nach Einschätzung des Prüfers für die Studiendauer pausiert, mit einer angemessenen Auswaschphase vor Beginn der Datenerfassung
  • Vorliegen eines körperlichen oder psychischen Zustands oder eines medizinischen Eingriffs, der nach Einschätzung des Prüfers die Durchführung der Verfahren und/oder deren Auswertung beeinträchtigen könnte
  • Schwangerschaft oder Stillzeit
  • Teilnahme an einer anderen klinischen Studie, die nach Einschätzung des Prüfers die Interpretation der Studienergebnisse beeinträchtigt

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time in target glucose range
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Substratoxidation
Zeitfenster: Einmal bei jeder phasenspezifischen Bewertung (frühfollikulär, präovulatorisch und luteal) für einen Menstruationszyklus beurteilt
Die Substratoxidation (d.h., quantifiziert durch den relativen Beitrag der Fettoxidation zum Ruheenergieumsatz) wird im nüchternen Zustand (≥8 Stunden) mittels indirekter Kalorimetrie gemessen, um zusätzlichen Kontext als physiologischen Determinanten des Glukose- und Energiestoffwechsels zu liefern. Dieses Ergebnis wird nur in einer Untergruppe von 15 Teilnehmern gemessen.
Einmal bei jeder phasenspezifischen Bewertung (frühfollikulär, präovulatorisch und luteal) für einen Menstruationszyklus beurteilt
Algorithm-directed insulin delivery following a standardized meal
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ruheenergieumsatz
Zeitfenster: Einmal bei jeder phasenspezifischen Bewertung (frühfollikulär, präovulatorisch und luteal) für einen Menstruationszyklus beurteilt.
Der Ruheenergieverbrauch (kcal/Tag) wird mittels indirekter Kalorimetrie im nüchternen Zustand (≥8 Stunden) gemessen, um zusätzlichen Kontext als physiologischen Determinanten des Energiestoffwechsels zu liefern. Dieses Ergebnis wird nur in einer Untergruppe von 15 Teilnehmern gemessen.
Einmal bei jeder phasenspezifischen Bewertung (frühfollikulär, präovulatorisch und luteal) für einen Menstruationszyklus beurteilt.
Patientenberichtete wahrgenommene Auswirkungen
Zeitfenster: Am Ende der Studie (nach drei Menstruationszyklen).
Die wahrgenommene Auswirkung des Menstruationszyklus auf die Diabeteskontrolle und -behandlung wird am Ende der Studie retrospektiv mithilfe eines Erfahrungsfragebogens erfasst.
Am Ende der Studie (nach drei Menstruationszyklen).
Postprandial mean glucose
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Lia Bally

Mitarbeiter

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
Gertrud and Walter Siegenthaler Foundation
Bangerter Foundation and Swiss Academy of Medical Science
Fresenius Kabi (Schweiz) AG
Bern Medtech Collaboration Call
mylife Diabetescare AG
Burgergemeinde Bern

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Mai 2025

Primärer Abschluss (Tatsächlich)

8. September 2026

Studienabschluss (Tatsächlich)

8. September 2026

Studienanmeldedaten

Zuerst eingereicht

22. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. März 2026

Zuerst gepostet (Tatsächlich)

17. März 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MCM-Loop

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Daten einzelner Teilnehmer (IPD) werden auf begründete Anfrage an den Hauptuntersucher zur Verfügung gestellt.

IPD-Sharing-Zeitrahmen

IPD wird ab 12 Monaten nach Veröffentlichung der Studienergebnisse verfügbar sein.

IPD-Sharing-Zugriffskriterien

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Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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