Status:
COMPLETED
Evaluating the Benefits of Physiologic Insulin Delivery
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04416737
Start Date
November 1 2021
End Date
June 2 2023
Last Update
October 1 2024
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304