Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes
18 oktober 2014 bijgewerkt door: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
28
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Ontario
-
Toronto, Ontario, Canada
- Mount Sinai Hospital
-
-
Quebec
-
Montreal, Quebec, Canada
- Institut de recherches cliniques de Montréal
-
Montreal, Quebec, Canada
- Montreal Children Hospital
-
-
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
12 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Males and females aged ≥ 12 years of old.
- Body mass index < 35
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 4 months.
- HbA1c < 12%.
- At least two visits with an endocrinology team in the past 1 year.
Exclusion Criteria:
- Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
- Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
- Failure to comply with team's recommendations.
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: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Conventional insulin pump therapry
Subjects will use conventional pump therapy to regulate their glucose levels.
|
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
|
|
Actieve vergelijker: Single-hormone closed-loop system
Variable subcutaneous insulin infusion rate will be used to regulate glucose levels.
Insulin Aspart (Novorapid) will be infused using a subcutaneous infusion pump.
The glucose level as measured by the real time sensor 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 recommendations of infusion rates.
|
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
|
|
Actieve vergelijker: Dual-hormone closed-loop system
Insulin Aspart (Novorapid) and glucagon (Paladin) will be infused using two separate subcutaneous infusion pumps.
The glucose levels as measured by the real time sensor will be entered manually into the computer every 10 minutes.
The pumps' infusion rate will then be changed manually based on the computer generated-recommendation delivery levels.
|
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of time in target range
Tijdsspanne: 8 hours
|
Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range.
Target range is defined to be between 4.0 to 8.0 mmol/L
|
8 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of time in target range for each night separately
Tijdsspanne: 8 hours
|
Percentage of time for which glucose levels are in target range for each night separately.
Target range is defined to be between 4.0 and 8.0 mmol/L.
|
8 hours
|
|
Percentage of time in target range for the pooled data
Tijdsspanne: 8 hours
|
Percentage of time for which glucose levels are in target range for the pooled data.
Target range is defined to be between 4.0 to 8.0 mmol/L.
|
8 hours
|
|
Percentage of time spent below 4.0 mmol/L
Tijdsspanne: 8 hours
|
Percentage of time for which glucose levels are below 4.0 mmol/L.
|
8 hours
|
|
Percentage of time spent below 3.3 mmol/L
Tijdsspanne: 8 hours
|
Percentage of time for which glucose levels are spent below 3.3 mmol/L.
|
8 hours
|
|
Area under the curve for glucose levels below 4.0 mmol/L
Tijdsspanne: 8 hours
|
8 hours
|
|
|
Area under the curve for glucose levels below 3.3 mmol/L
Tijdsspanne: 8 hours
|
8 hours
|
|
|
Percentage of time spent above 8.0 mmol/L
Tijdsspanne: 8 hours
|
Percentage of time for which glucose levels are above 8.0 mmol/L
|
8 hours
|
|
Percentage of time spent above 10.0 mmol/L
Tijdsspanne: 8 hours
|
Percentage of time for which glucose levels are above 10.0 mmol/L.
|
8 hours
|
|
Area under the curve for glucose levels spent above 8.0 mmol/L
Tijdsspanne: 8 hours
|
8 hours
|
|
|
Area under the curve for glucose levels spent above 10.0 mmol/L
Tijdsspanne: 8 hours
|
8 hours
|
|
|
Mean glucose levels
Tijdsspanne: 8 hours
|
8 hours
|
|
|
Standard deviation of glucose levels
Tijdsspanne: 8 hours
|
Standard deviation of glucose levels as a measure of glucose variability.
|
8 hours
|
|
Total insulin delivery
Tijdsspanne: 8 hours
|
8 hours
|
|
|
Number of subjects experiencing at least one hypoglycemic event requiring treatment
Tijdsspanne: 8 hours
|
8 hours
|
|
|
Number of hypoglycemic events requiring treatment
Tijdsspanne: 8 hours
|
8 hours
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Bruce Perkins, Mount Sinai Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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
1 juli 2013
Primaire voltooiing (Werkelijk)
1 september 2014
Studie voltooiing (Werkelijk)
1 september 2014
Studieregistratiedata
Eerst ingediend
12 juli 2013
Eerst ingediend dat voldeed aan de QC-criteria
17 juli 2013
Eerst geplaatst (Schatting)
22 juli 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
21 oktober 2014
Laatste update ingediend die voldeed aan QC-criteria
18 oktober 2014
Laatst geverifieerd
1 oktober 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CLASS-04
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .