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Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes

28. januar 2020 opdateret af: Jennifer Sherr
"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Open-label, crossover study comparing the peak post-prandial glucose levels and the incremental post-prandial glucose area under the curve (AUC) during closed loop (CL) control alone and during CL control with liraglutide in an inpatient research setting. Data generated during outpatient baseline evaluation and liraglutide dose titration phases of the study will be compared to assess the short-term efficacy of this agent during open-loop continuous subcutaneous insulin infusion (CSII) pump treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School Of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. age 18-40 years
  2. clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
  3. duration of T1D ≥ 1 year
  4. HbA1c ≤ 9 %
  5. Treated with CSII for at least 3 months
  6. Body weight > 50 kg (to accommodate phlebotomy)
  7. Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct

Exclusion Criteria:

  1. Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
  2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
  3. Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
  4. History of hypoglycemic seizure within last 3 months
  5. Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
  6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
  7. History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
  8. Taking a medication known to affect gastric motility
  9. History of pancreatitis, gallstones, alcoholism or high triglyceride levels
  10. Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
  11. Subjects unable to give consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Closed Loop Insulin Delivery

Each participant recruited into the study will undergo two inpatient closed loop admissions.

The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.

Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.

Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.
Enhed: ePID lukket kredsløb
Insulinpumpe styret af lukket sløjfeenhed og algoritme
Medicin: liraglutide
Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
Andre navne:
  • Victoza

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak Post-prandial Venous Glucose Levels
Tidsramme: 48 hours
peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide
48 hours

Sekundære resultatmål

Resultatmål
Tidsramme
the Incremental Meal-related Glucose Area Under Curve (AUC)
Tidsramme: 5-hour post prandial period after breakfast, lunch, and dinner
5-hour post prandial period after breakfast, lunch, and dinner

Andre resultatmål

Resultatmål
Tidsramme
Mean 24-hour Glucose Levels
Tidsramme: 24- hours
24- hours
Mean Time to Peak Post-meal Glucose Value
Tidsramme: 5- hour postprandial period
5- hour postprandial period
Mean Daytime Glucose Levels
Tidsramme: 8a.m.-11p.m.
8a.m.-11p.m.
Incremental Glucagon Peak
Tidsramme: 5 hours
5 hours
AUC Plasma Glucagon During MMTT
Tidsramme: 2 hours
2 hours
Differences in Daily Insulin Requirements
Tidsramme: 24 hours
24 hours
Prandial Insulin Delivery During Closed Loop Therapy
Tidsramme: Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
Mean Nocturnal Glucose Levels
Tidsramme: 11p.m.-6a.m.
11p.m.-6a.m.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jennifer Sherr

Samarbejdspartnere

Yale University
Juvenile Diabetes Research Foundation

Efterforskere

  • Ledende efterforsker: Jennifer Sherr, MD, PhD, Yale University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2013

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. november 2015

Datoer for studieregistrering

Først indsendt

14. maj 2013

Først indsendt, der opfyldte QC-kriterier

14. maj 2013

Først opslået (Skøn)

17. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1211011156

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med ePID lukket kredsløb

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Betingelser

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