Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy

• Status: Completed
• Trial end date: 2016-07-01
• 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. Specifically, we will be looking to see if using hyaluronidase improves the ability of the closed loop artificial pancreas to better respond to meal related highs and lows.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eda Cengiz
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. age 12-40 years

2. clinical diagnosis of T1D based on ADA criteria or presence of DKA at diagnosis (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 > 37 kg (to accommodate phlebotomy)

7. Normal hematocrit

8. Normal creatinine

9. Not pregnant or lactating, and for female subjects of reproductive potential, are abstinent or are consistently using barrier or hormonal methods of contraception

Exclusion Criteria:

1. Insulin resistant (defined as requiring > 2 units/kg/day at time of study enrollment

2. Previous allergic reaction to PH20

3. Inability to comprehend written or spoken English

4. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct

5. Use of any medications (besides insulin) known to affect 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

6. Use of furosemide, benzodiazepines or phenytoin during the study

7. History of poor wound healing, heat sensitivity, or diminished skin integrity.

8. History of hypoglycemic seizure within last 3 months

9. Anemic (low hematocrit), or evidence of renal insufficiency (elevated serum creatinine)

10. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

11. Subjects unable to give consent / permission / assent