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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Jennifer Sherr
Study ID
NCT01856790
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • ePID closed loop system — DEVICE
    Insulin pump controlled by closed loop unit and algorithm
  • liraglutide — DRUG
    Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist

Study Details

"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.

Key Dates

Start date
Feb 28, 2013
Status verified
Jan 2020
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Peak Post-prandial Venous Glucose Levels [ Time Frame: 48 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Yale University School of Medicine· New Haven, CT

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