Phase 1
N=16
Evaluating the Benefits of Physiologic Insulin Delivery
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04416737 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Glucagon Response to Induced Hypoglycemia — 4.8; 8.8; 5.8; 4.2 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ultra-rapid insulin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucagon Response to Induced Hypoglycemia |
4.8; 8.8; 5.8; 4.2 | — |
| SECONDARY Insulin Maximum Concentration in Plasma |
56.81; 63.26; 56.95; 57.47 | — |
| SECONDARY Hypoglycemic Treatments Required as a Measure of Glucose Values |
1; 1; 1; 3 | — |
| SECONDARY Time Until Maximum Insulin Concentration in Plasma |
35; 25; 30; 60 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04416737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.