Evaluating the Benefits of Physiologic Insulin Delivery

Type 1 Diabetes Clinical Trial

Official title:

Evaluating the Benefits of Physiologic Insulin Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416737
• Other study ID #: IRB-57032
• Secondary ID: 1K23DK122017
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The eventual goal of this line of work is an implanted insulin pump that delivers insulin automatically into the peritoneum based on continuous glucose data. All prior intraperitoneal pharmacokinetic studies used only concentrated regular insulin, which may be too slow to provide full closed-loop insulin delivery without meal announcement. A description of intraperitoneal ultra-rapid insulin kinetics, as well as counter-regulatory hormonal factors that may counter hypoglycemia is needed. Upper versus lower peritoneal delivery may also affect insulin kinetics. A possible benefit of intraperitoneal insulin is restoration of glucagon response in longstanding diabetes and clearance of insulin by the liver, both of which could provide hypoglycemic rescue in automated insulin delivery systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Ultra-rapid insulin
Following 0.5-3 hours of insulin suspension from insulin pump, participants will receive insulin injection in respective locations (separated by at least 1 week) and then have serial lab measurements (YSI glucose, insulin and glucagon) taken during induced hypoglycemia.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon response to induced hypoglycemia	For each injection site we will assess the change in glucagon from nadir to peak during induced hypoglycemia.	Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Secondary	Insulin concentration in plasma		Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Secondary	Glucose Values		Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max