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

NCT ID: NCT01856790

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-11-30

Brief Summary

"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.

Detailed Description

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ePID closed loop system

Intervention Type: DEVICE

Insulin pump controlled by closed loop unit and algorithm

liraglutide

Intervention Type: DRUG

Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist

Interventions

ePID closed loop system

Insulin pump controlled by closed loop unit and algorithm

Intervention Type: DEVICE

liraglutide

Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist

Intervention Type: DRUG

Other Intervention Names

Victoza

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Jennifer Sherr

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Sherr

Instructor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Sherr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1211011156

Identifier Type: -

Identifier Source: org_study_id