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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Fase

  • Fase 2

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
Apparaat: Insulin pump
The participant's insulin pump will be used to infuse insulin
Apparaat: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Ander: 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.
Actieve vergelijker: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
Apparaat: Insulin pump
The participant's insulin pump will be used to infuse insulin
Apparaat: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in plasma glucose levels 1 hour after the meal
Tijdsspanne: 1 hour
1 hour

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Institut de Recherches Cliniques de Montreal

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 april 2018

Primaire voltooiing (Verwacht)

31 december 2018

Studie voltooiing (Verwacht)

31 december 2018

Studieregistratiedata

Eerst ingediend

3 november 2017

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2017

Eerst geplaatst (Werkelijk)

7 november 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 april 2018

Laatste update ingediend die voldeed aan QC-criteria

25 april 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLASS-FiAsp

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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