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Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels

25. April 2018 aktualisiert von: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.

The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.

Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.

Studienübersicht

Status

Zurückgezogen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Phase

  • Phase 2

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 und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Males and females ≥ 18 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. The subject will have been on insulin pump therapy for at least 6 months.
  4. HbA1c ≤ 12%.

Exclusion Criteria:

  1. Using a patch-pump (e.g. Omnipod)
  2. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  3. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  4. Ongoing or planned pregnancy.
  5. Breastfeeding.
  6. Severe hypoglycemic episode within two weeks of screening.
  7. Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
  8. Known or suspected allergy to the trial products or meal contents.
  9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  10. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
  11. Problems with venous access.

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: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
Gerät: Insulin pump
The participant's insulin pump will be used to infuse insulin
Gerät: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Sonstiges: 11-hour intervention with the single-hormone artificial pancreas

Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.

Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.
Aktiver Komparator: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
Gerät: Insulin pump
The participant's insulin pump will be used to infuse insulin
Gerät: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Sonstiges: 11-hour intervention with the single-hormone artificial pancreas

Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.

Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change in plasma glucose levels 1 hour after the meal
Zeitfenster: 1 hour
1 hour

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Zeitfenster: 1 hour
1 hour
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Zeitfenster: 2 hours
2 hours
Plasma glucose level 1 hour after the meal.
Zeitfenster: 1 hour
1 hour
Plasma glucose level 2 hours after the meal.
Zeitfenster: 2 hours
2 hours
Glycemic peak in the 3 hours following the meal.
Zeitfenster: 3 hours
3 hours
Change in plasma glucose levels 2 hours after the meal.
Zeitfenster: 2 hours
2 hours
Peak time of glucose levels over the 4 hours following the meal.
Zeitfenster: 4 hours
4 hours
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Zeitfenster: 4 hours
4 hours
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of plasma glucose levels above 10 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels above 10 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of plasma glucose levels above 13.9 mmol/L
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels above 13.9 mmol/L
Zeitfenster: 11 hours
11 hours
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Zeitfenster: 11 hours
11 hours
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Zeitfenster: 11 hours
11 hours
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Zeitfenster: 11 hours
11 hours
Standard deviation of plasma glucose levels.
Zeitfenster: 11 hours
11 hours
Standard deviation of sensor glucose levels.
Zeitfenster: 11 hours
11 hours
Coefficient of variance of plasma glucose levels.
Zeitfenster: 11 hours
11 hours
Coefficient of variance of sensor glucose levels.
Zeitfenster: 11 hours
11 hours
Total insulin delivery.
Zeitfenster: 11 hours
11 hours
Mean plasma glucose level.
Zeitfenster: 11 hours
11 hours
Mean sensor glucose level.
Zeitfenster: 11 hours
11 hours
Mean plasma insulin concentration.
Zeitfenster: 11 hours
11 hours
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Zeitfenster: 11 hours
11 hours

Mitarbeiter und Ermittler

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

Sponsor

Institut de Recherches Cliniques de Montreal

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 (Voraussichtlich)

1. April 2018

Primärer Abschluss (Voraussichtlich)

31. Dezember 2018

Studienabschluss (Voraussichtlich)

31. Dezember 2018

Studienanmeldedaten

Zuerst eingereicht

3. November 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2017

Zuerst gepostet (Tatsächlich)

7. November 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. April 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. April 2018

Zuletzt verifiziert

1. April 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CLASS-FiAsp

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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