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Evaluating the Benefits of Physiologic Insulin Delivery

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ultra-rapid insulin

About this trial

This is an interventional other trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Upper Peritoneal, then Lower Peritoneal, then Subcutaneous

Lower Peritoneal, then Upper Peritoneal, then Subcutaneous

Arm Description

Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.

Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.

Outcomes

Primary Outcome Measures

Glucagon response to induced hypoglycemia

For each injection site we will assess the change in glucagon from nadir to peak during induced hypoglycemia.

Secondary Outcome Measures

Insulin concentration in plasma

Glucose Values

Full Information

NCT ID

NCT04416737

First Posted

June 2, 2020

Last Updated

June 5, 2023

Sponsor

Stanford University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT04416737

Brief Title

Evaluating the Benefits of Physiologic Insulin Delivery

Official Title

Evaluating the Benefits of Physiologic Insulin Delivery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

June 2, 2023 (Actual)

Study Completion Date

June 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Participants will each come in for 3 visits separated by at least 1 week. During the first two visits they will be randomized to either upper or lower peritoneal injection followed by the other site. During the third visit a subcutaneous injection will be performed to provide comparative data to the standard of care.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Upper Peritoneal, then Lower Peritoneal, then Subcutaneous

Arm Type

Experimental

Arm Description

Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.

Arm Title

Lower Peritoneal, then Upper Peritoneal, then Subcutaneous

Arm Type

Experimental

Arm Description

Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.

Intervention Type

Other

Intervention Name(s)

Ultra-rapid insulin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Glucagon response to induced hypoglycemia

Description

For each injection site we will assess the change in glucagon from nadir to peak during induced hypoglycemia.

Time Frame

Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max

Secondary Outcome Measure Information:

Title

Insulin concentration in plasma

Time Frame

Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max

Title

Glucose Values

Time Frame

Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rayhan Lal, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No current plan

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Evaluating the Benefits of Physiologic Insulin Delivery

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