Summary

Eligibility
for people ages 13-18 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Laya Ekhlaspour, MD

Description

Summary

This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.

Official Title

Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes

Keywords

Type 1 Diabetes, Diabetes Mellitus, Type 1, Insulin, Insulin, Globin Zinc

Eligibility

You can join if…

Open to people ages 13-18

  • Age between 13 and 18 years old, A1C > 6% at screening
  • Diagnosed with type 1 diabetes for at least one year
  • Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day
  • Currently using the Control IQ closed-loop system
  • Willing to abide by meal recommendations and study procedures
  • Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF
  • Use an Android or Apple smartphone
  • Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
  • Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
  • Parent/guardian proficient in reading and writing English
  • Live in the United States, with no plans to move outside the United States during the study period

You CAN'T join if...

  • A1C >10%
  • One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months
  • Used non-insulin anti-diabetic medication within the last 30 days other than metformin
  • Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease
  • Pregnancy or lactation
  • Untreated or unstable hypothyroidism
  • Currently undergoing cancer treatment or systemic treatment with steroids
  • Untreated or inadequately treated mental illness
  • Current alcohol abuse
  • Current illness that would interfere with participation in the study
  • Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying
  • Celiac Disease

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Laya Ekhlaspour, MD
    Assistant Professor, Pediatrics, School of Medicine. Authored (or co-authored) 41 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05454891
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated