Evaluating the Benefits of Physiologic Insulin Delivery
Trial ID or NCT#
NCT04416737
Status
NOT RECRUITING
Purpose
In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. We will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.
Official Title
Evaluating the Benefits of Physiologic Insulin Delivery
Eligibility Criteria
Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. 18-60 years of age 2. Clinical diagnosis of type 1 diabetes 3. On insulin pump therapy and continuous glucose monitor (CGM) for at least 3 months 4. Ability to safely receive intraperitoneal injection 5. For females, not currently known to be pregnant 6. Understanding and willingness to follow the protocol and sign informed consent 7. Ability to speak, read and write in the language of the investigators
Exclusion Criteria:
- 1. Diabetic ketoacidosis in the past 3 months 2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment 3. Pregnant or lactating 4. Active infection 5. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 6. Known cardiovascular events in the last 6 months 7. Known seizure disorder 8. Inpatient psychiatric treatment in the past 6 months 9. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication. 10. Suspected drug or alcohol abuse 11. Chronic kidney disease (GFR < 60 mL/min/1.73m^2)
Investigator(s)
Rayhan A. Lal, MD
Endocrinologist
Assistant Professor of Medicine (Endocrinology) and of Pediatrics (Endocrinology)
Contact us to find out if this trial is right for you.
Contact
Ryan Kingman
View on ClinicalTrials.gov
