Evaluating the Benefits of Physiologic Insulin Delivery

  • STATUS
    Recruiting
  • End date
    Jun 18, 2023
  • participants needed
    15
  • sponsor
    Stanford University
Updated on 18 May 2022
diabetes
insulin
glucagon
hypoglycemia
injection of insulin

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.

Details
Condition Type 1 Diabetes
Treatment Ultra-rapid insulin
Clinical Study IdentifierNCT04416737
SponsorStanford University
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

18-60 years of age
Clinical diagnosis of type 1 diabetes
On insulin pump therapy and continuous glucose monitor (CGM) for at least 3 months
Ability to safely receive intraperitoneal injection
For females, not currently known to be pregnant
Understanding and willingness to follow the protocol and sign informed consent
Ability to speak, read and write in the language of the investigators

Exclusion Criteria

Diabetic ketoacidosis in the past 3 months
Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
Pregnant or lactating
Active infection
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
Known cardiovascular events in the last 6 months
Known seizure disorder
Inpatient psychiatric treatment in the past 6 months
Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication
Suspected drug or alcohol abuse
Chronic kidney disease (GFR < 60 mL/min/1.73m^2)
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