Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
8. februar 2019 oppdatert av: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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 artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
37
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Quebec
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Montreal, Quebec, Canada, H2W 1R7
- Institut de recherches cliniques de Montréal
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-
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:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- 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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Unannounced exercise
The target blood glucose of the algorithm will be as usual.
A pre-meal full insulin bolus will be given.
|
Pasientens vanlige hurtigvirkende insulinanalog vil bli brukt.
Dexcom G4 Platinum glukosesensor vil bli brukt til å måle glukosenivåer.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
|
Aktiv komparator: Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
|
Pasientens vanlige hurtigvirkende insulinanalog vil bli brukt.
Dexcom G4 Platinum glukosesensor vil bli brukt til å måle glukosenivåer.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
|
Aktiv komparator: Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
|
Pasientens vanlige hurtigvirkende insulinanalog vil bli brukt.
Dexcom G4 Platinum glukosesensor vil bli brukt til å måle glukosenivåer.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Tidsramme: From 9:30 to 11:30 (120 minutes)
|
From 9:30 to 11:30 (120 minutes)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Tidsramme: From 8:00 to 10:50 (170 minutes)
|
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
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From 8:00 to 10:50 (170 minutes)
|
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Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Tidsramme: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Decremental area under the curve from the start of the exercise
Tidsramme: From 9:30 to 11:00 (90 minutes)
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From 9:30 to 11:00 (90 minutes)
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Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Tidsramme: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Tidsramme: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Tidsramme: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Tidsramme: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent above 10 mmol/L
Tidsramme: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Tidsramme: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Tidsramme: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Mean plasma glucose levels
Tidsramme: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
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Standard deviation of glucose levels
Tidsramme: From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
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Coefficient of variation of glucose levels
Tidsramme: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
|
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Mean time (minutes) to the first hypoglycemic event
Tidsramme: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Samarbeidspartnere og etterforskere
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Publikasjoner og nyttige lenker
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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
1. september 2016
Primær fullføring (Faktiske)
1. desember 2018
Studiet fullført (Faktiske)
1. desember 2018
Datoer for studieregistrering
Først innsendt
1. august 2016
Først innsendt som oppfylte QC-kriteriene
1. august 2016
Først lagt ut (Anslag)
4. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i immunsystemet
- Autoimmune sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 1
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Hormoner, hormonsubstitutter og hormonantagonister
- Insulin
- Insulin, Globin sink
- Hormoner
Andre studie-ID-numre
- CLASS-16
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
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