Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 10/14/2017 |
| Start Date: | February 2013 |
| End Date: | November 2015 |
"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.
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.
Open-label, crossover study comparing the peak post-prandial glucose levels and the
incremental post-prandial glucose AUC during 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 CSII pump treatment.
incremental post-prandial glucose AUC during 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 CSII pump treatment.
Inclusion Criteria:
1. age 18-40 years
2. clinical diagnosis of 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
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
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