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Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2

25 april 2017 bijgewerkt door: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). It is however important to establish the safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop will be tested.

Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

11

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Institut de recherches cliniques de Montréal

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 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 3 months and currently using a fast acting insulin analog (Lispro, Aspart or Glulisine).
  4. Last (less than 3 months) HbA1c ≤ 10%.
  5. Currently using carbohydrate counting as the meal insulin dose strategy.

Exclusion Criteria:

  1. 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.
  2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  3. Pregnancy.
  4. Severe hypoglycemic episode within 1 month of screening.
  5. Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
  6. Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable.
  7. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition).
  8. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).

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: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Dual-hormone CL with overestimation of meal size category
A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
Geneesmiddel: Glucagon
Glucagon (Eli Lilly) zal worden gebruikt tijdens een gesloten-lusstrategie met twee hormonen.
Apparaat: Dexcom G4 Platinum-glucosesensor
Apparaat: Accu Chek Combo insulinepomp
Ander: Dual-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00.
Geneesmiddel: Insulin
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).
Actieve vergelijker: Dual-hormone CL with adequate estimation of meal size category
A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 35g of carbohydrates.
Geneesmiddel: Glucagon
Glucagon (Eli Lilly) zal worden gebruikt tijdens een gesloten-lusstrategie met twee hormonen.
Apparaat: Dexcom G4 Platinum-glucosesensor
Apparaat: Accu Chek Combo insulinepomp
Ander: Dual-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00.
Geneesmiddel: Insulin
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Percentage of time below 4.0 mmol/L
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Mean glucose
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations below 3.1 mmol/L
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 4.0 mmol/L
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 3.1 mmol/L
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Number of patients with at least one hypoglycemic event with or without symptoms
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total number of hypoglycemic event below 3.1 mmol/L
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total carbohydrate intake for hypoglycemia correction
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total insulin delivery
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total glucagon delivery
Tijdsspanne: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.

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

1 juni 2016

Primaire voltooiing (Werkelijk)

1 maart 2017

Studie voltooiing (Werkelijk)

1 maart 2017

Studieregistratiedata

Eerst ingediend

9 juni 2016

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2016

Eerst geplaatst (Schatting)

14 juni 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 april 2017

Laatste update ingediend die voldeed aan QC-criteria

25 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLASS-Safety study - Part 2

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