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Evaluating the Benefits of Physiologic Insulin Delivery

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ClinicalTrials.gov Identifier: NCT04416737
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Rayhan A. Lal, Stanford University

Tracking Information
First Submitted Date  ICMJE June 2, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date June 4, 2020
Estimated Study Start Date  ICMJE June 2022
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
Glucagon response to induced hypoglycemia [ Time Frame: Peritoneal: Every 5 minutes for 100 minutes max; Subcutaneous: Every 15 minutes for 240 minutes max ]
For each injection site we will assess the change in glucagon from nadir to peak during induced hypoglycemia.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Insulin concentration in plasma [ Time Frame: Peritoneal: Every 5 minutes for 100 minutes max; Subcutaneous: Every 15 minutes for 240 minutes max ]
  • Glucose Values [ Time Frame: Peritoneal: Every 5 minutes for 100 minutes max; Subcutaneous: Every 15 minutes for 240 minutes max ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Benefits of Physiologic Insulin Delivery
Official Title  ICMJE Evaluating the Benefits of Physiologic Insulin Delivery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Other: Ultra-rapid insulin
Following 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.
Study Arms  ICMJE
  • Experimental: Upper Peritoneal, then Lower Peritoneal, then Subcutaneous
    Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.
    Intervention: Other: Ultra-rapid insulin
  • Experimental: Lower Peritoneal, then Upper Peritoneal, then Subcutaneous
    Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.
    Intervention: Other: Ultra-rapid insulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rayhan Lal, MD 650-725-6549 inforay@stanford.edu
Contact: Bruce Buckingham, MD 650-804-0476 bbendo@stanford.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04416737
Other Study ID Numbers  ICMJE IRB-57032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No current plan
Responsible Party Rayhan A. Lal, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Rayhan Lal, MD Stanford University
PRS Account Stanford University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP