ACTIVE_NOT_RECRUITING

Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to evaluate the effect of a wearable insulin pump on blood sugar levels during sleep. The study device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep. The study device does not replace long-acting, correction, or mealtime insulin. The study will involve applying the study device before bed for a period of 13 weeks. The overall study length is approximately 17 weeks. The study aims to evaluate whether the study device is safe and if it lowers blood sugar levels in people who have consistently high blood sugar during sleep and at wake.

Official Title

Automated Insulin Delivery for Multiple Daily Injectors (AID4MDI)

Quick Facts

Study Start:2024-11-22
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06627517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jeremy H Pettus, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

Diablo Clinical Research
Walnut Creek, California, 94598
United States
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
United States
International Diabetes Center
Minneapolis, Minnesota, 55416
United States

Collaborators and Investigators

Sponsor: Luna Diabetes

  • Jeremy H Pettus, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-22
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-11-22
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • overnight hyperglycemia
  • sleep quality
  • type 1 diabetes
  • closed loop

Additional Relevant MeSH Terms

  • Type 1 Diabetes Mellitus
  • Sleep Quality