Overview

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

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jennifer Sherr
Collaborators:
Juvenile Diabetes Research Foundation
Yale University
Treatments:
Liraglutide
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