- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01856790
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Tidig fas 1
Kontakter och platser
Studieorter
-
-
Connecticut
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New Haven, Connecticut, Förenta staterna, 06520
- Yale University School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- age 18-40 years
- clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
- duration of T1D ≥ 1 year
- HbA1c ≤ 9 %
- Treated with CSII for at least 3 months
- Body weight > 50 kg (to accommodate phlebotomy)
- 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:
- Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- 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
- History of hypoglycemic seizure within last 3 months
- Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
- History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
- Taking a medication known to affect gastric motility
- History of pancreatitis, gallstones, alcoholism or high triglyceride levels
- Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
- Subjects unable to give consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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. |
Insulinpump styrd av sluten slinga enhet och algoritm
Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Peak Post-prandial Venous Glucose Levels
Tidsram: 48 hours
|
peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide
|
48 hours
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
the Incremental Meal-related Glucose Area Under Curve (AUC)
Tidsram: 5-hour post prandial period after breakfast, lunch, and dinner
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5-hour post prandial period after breakfast, lunch, and dinner
|
Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Mean 24-hour Glucose Levels
Tidsram: 24- hours
|
24- hours
|
Mean Time to Peak Post-meal Glucose Value
Tidsram: 5- hour postprandial period
|
5- hour postprandial period
|
Mean Daytime Glucose Levels
Tidsram: 8a.m.-11p.m.
|
8a.m.-11p.m.
|
Incremental Glucagon Peak
Tidsram: 5 hours
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5 hours
|
AUC Plasma Glucagon During MMTT
Tidsram: 2 hours
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2 hours
|
Differences in Daily Insulin Requirements
Tidsram: 24 hours
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24 hours
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Prandial Insulin Delivery During Closed Loop Therapy
Tidsram: Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
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Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
|
Mean Nocturnal Glucose Levels
Tidsram: 11p.m.-6a.m.
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11p.m.-6a.m.
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jennifer Sherr, MD, PhD, Yale University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Immunsystemets sjukdomar
- Autoimmuna sjukdomar
- Sjukdomar i det endokrina systemet
- Diabetes mellitus
- Diabetes mellitus, typ 1
- Hypoglykemiska medel
- Läkemedels fysiologiska effekter
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Inkretiner
- Liraglutid
Andra studie-ID-nummer
- 1211011156
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