RECRUITING

Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes

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Conditions

Type 2 DiabetesAutomated Insulin Delivery (AID)Continuous Glucose Monitor (CGM)Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ)Basal Insulin Titration (BIT)

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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 clinical trial is to test the safety and feasibility of using an Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration. Participants will be randomized to either the control group or the experimental group. If in the experimental group, the participant will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days. Researchers will compare the glycemic control of the experimental group to the control group.

Official Title

Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: a Pilot Study

Quick Facts

Study Start:2024-06-18
Study Completion:2025-01-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06024928

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. 1. Age ≥18.0 years old at time of consent.
  2. 2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
  3. 3. HbA1c ≥ 7.5%.
  4. 4. Currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec)
  5. 5. Willingness to discontinue a personal CGM during the duration of the study.
  6. 6. Access to the internet and willingness to upload data during the study as needed.
  7. 7. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  8. 8. Willingness not to start any new non-insulin glucose-lowering agent during the trial (including metformin/biguanides, Glucagon-like peptide (GLP)-1 receptor agonists, pramlintide, Dipeptidyl peptidase (DPP)-4 inhibitors, sulfonylureas and nutraceuticals).
  1. 1. Treatment with meglitinides/sulfonylureas.
  2. 2. Currently using an approved intermediate (e.g., insulin Neutral Protamine Hagedorn (NPH)) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular).
  3. 3. Currently being treated for a seizure disorder.
  4. 4. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples: a) Inpatient psychiatric treatment in the past 6 months, b) Presence of a known adrenal disorder, c) Uncontrolled thyroid disease.
  5. 5. Currently pregnant or intent to become pregnant during the trial.
  6. 6. Currently breastfeeding.

Contacts and Locations

Study Contact

Lianna Smith
CONTACT
434-243-6681
lhs7px@uvahealth.org
Carlene Alix
CONTACT
434-249-8961
uax8yx@uvahealth.org

Principal Investigator

Anas El Fathi, PhD
PRINCIPAL_INVESTIGATOR
University of Virginia Center for Diabetes Technology

Study Locations (Sites)

University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Anas El Fathi, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia Center for Diabetes Technology

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 Date2024-06-18
Study Completion Date2025-01-14

Study Record Updates

Study Start Date2024-06-18
Study Completion Date2025-01-14

Terms related to this study

Keywords Provided by Researchers

  • Automated Insulin Delivery (AID)
  • Continuous Glucose Monitor (CGM)
  • Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ)
  • Basal Insulin Titration (BIT)

Additional Relevant MeSH Terms

  • Type 2 Diabetes