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MD Logic Pump Advisor- Adults Study

10. Januar 2017 aktualisiert von: Rabin Medical Center

Evaluation of Automated Insulin Pump Settings Using the MD-Logic Pump Advisor-Adults Sub Study

Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as input, sensor readings, insulin delivery and recording of the meals during home care. During collection of the data, the patients are asked to continue their daily routine (no need for special consideration).

The present study was designed to test the automatic algorithm that will evaluate and change, when necessary, the patient's insulin pump settings based on prior sensor reading, insulin delivery, and meals data that was collected while the patient is under his regular treatment at home.

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.

The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Endpoints:

  • Primary endpoint Increase in time spent in the normal range, defined as sensor glucose level within 70 to 180 mg/dl
  • Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70 mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose variability, quality of life measurements and subject treatment satisfaction.

Inclusion Criteria:

  • Subject with Type 1 diabetes (>1yr since diagnosis)
  • Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII (continuous subcutaneous insulin infusion) therapy for at least 3 months
  • Age ≥ 18 years
  • HbA1c at inclusion ≥ 6.0%
  • No concomitant diseases that influence metabolic control
  • No current use of CGM
  • Subjects do not participate in any other interventional study

Studientyp

Interventionell

Einschreibung (Tatsächlich)

18

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Israel
      • Petaach-Tikva, Israel, 49202
        • Schneider Children's Medical Center
  • Slowenien
      • Ljubljana, Slowenien
        • University Children's 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

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Subject with Type 1 diabetes (>1yr since diagnosis)
  2. Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
  3. Age ≥ 18 years
  4. HbA1c at inclusion ≥ 6.0%
  5. No concomitant diseases that influence metabolic control
  6. No current use of CGM
  7. Subjects do not participate in any other interventional study

Exclusion Criteria:

  1. Known or suspected allergy to trial products.
  2. Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
  3. Subject is currently using CGM device
  4. Diabetic ketoacidosis in the past 3 months.
  5. Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
  6. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
  7. Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
  8. Female subject who is pregnant or planning to become pregnant within the planned study duration

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: intervantion group
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor.
Gerät: MD Logic Pump Advisor
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
Kein Eingriff: control group
Regular treatment, No change will be made in the insulin pump setting during the study(unless there is a medical need or any safety concern).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time spent in the normal range
Zeitfenster: during each 6 days iteration
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
during each 6 days iteration

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Zeitfenster: Day 78
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Day 78
time spent above 180 mg/dl
Zeitfenster: during each 6 days iteration
time spent above 180 mg/dl
during each 6 days iteration
time spent below 70 mg/dl
Zeitfenster: during each 6 days iteration
time spent below 70 mg/dl
during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
Zeitfenster: during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
during each 6 days iteration
Adverse event
Zeitfenster: during each 6 days iteration
Adverse event
during each 6 days iteration
glucose variability- area under the curve
Zeitfenster: during each 6 days iteration
glucose variability measured as area under the curve (the area between the measured blood glucose and the glucose level of 180 mg/dl) and area above the curve (the area between the measured blood glucose and the glucose level of 70 mg/dl
during each 6 days iteration
Quality of Life Questionaires
Zeitfenster: At the end of the study- day 30 -78
Quality of Life Questionaires
At the end of the study- day 30 -78
Number of MDLAP-recommendations that were rejected by the physician
Zeitfenster: during each 6 days iteration
Number of MDLAP-recommendations that were rejected by the physician
during each 6 days iteration
Number and type of changes in any pump setting per iteration
Zeitfenster: during each 6 days iteration
Number and type of changes in any pump setting per iteration
during each 6 days iteration

Mitarbeiter und Ermittler

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

Sponsor

Rabin Medical Center

Mitarbeiter

Medtronic

Ermittler

  • Hauptermittler: Moshe Phillip, Prof, Schenider Children's Medical

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

1. Juli 2010

Primärer Abschluss (Tatsächlich)

1. Juli 2016

Studienabschluss (Tatsächlich)

1. Juli 2016

Studienanmeldedaten

Zuerst eingereicht

27. Juni 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juli 2010

Zuerst gepostet (Schätzen)

7. Juli 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

11. Januar 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Januar 2017

Zuletzt verifiziert

1. Januar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • rmc005816ctil

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