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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 oppdatert av: 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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Fase

  • Fase 2

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
Enhet: Insulin pump
The participant's insulin pump will be used to infuse insulin
Enhet: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Annen: 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.
Aktiv komparator: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
Enhet: Insulin pump
The participant's insulin pump will be used to infuse insulin
Enhet: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in plasma glucose levels 1 hour after the meal
Tidsramme: 1 hour
1 hour

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut de Recherches Cliniques de Montreal

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. april 2018

Primær fullføring (Forventet)

31. desember 2018

Studiet fullført (Forventet)

31. desember 2018

Datoer for studieregistrering

Først innsendt

3. november 2017

Først innsendt som oppfylte QC-kriteriene

3. november 2017

Først lagt ut (Faktiske)

7. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. april 2018

Sist bekreftet

1. april 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLASS-FiAsp

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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