RECRUITING

Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

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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

This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.

Official Title

Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

Quick Facts

Study Start:2024-09-09

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05696366

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 to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening; 2. Females of non-childbearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product; 3. Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period; 4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria; 5. Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump or hybrid closed loop system; 6. Currently using a Continuous Glucose Monitoring (CGM) system; 7. A1c \> 7% and ≤ 10% 8. eGFR ≥ 60 mL/min/1.73m²; 9. Able to provide written informed consent approved by an Institutional Review Board (IRB).	1. History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion; 2. History of pancreatitis, medullary thyroid carcinoma or liver disease; 3. Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening); 4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg; 5. Body Mass Index (BMI) \> 35 kg/m2 6. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion; 7. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1 RA, SGLT-2i, Pramlintide, Metformin); 8. Women who are pregnant or lactating/breastfeeding; 9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits; 10. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

Inclusion Criteria

Exclusion Criteria

1. Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening;
2. Females of non-childbearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product;
3. Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period;
4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
5. Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump or hybrid closed loop system;
6. Currently using a Continuous Glucose Monitoring (CGM) system;
7. A1c \> 7% and ≤ 10%
8. eGFR ≥ 60 mL/min/1.73m²;
9. Able to provide written informed consent approved by an Institutional Review Board (IRB).

1. History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
2. History of pancreatitis, medullary thyroid carcinoma or liver disease;
3. Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
5. Body Mass Index (BMI) \> 35 kg/m2
6. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;
7. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1 RA, SGLT-2i, Pramlintide, Metformin);
8. Women who are pregnant or lactating/breastfeeding;
9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
10. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

Contacts and Locations

Study Contact

Schafer Boeder

CONTACT

858-246-2161

sboeder@health.ucsd.edu

Todd May

CONTACT

858-246-2169

tmay@health.ucsd.edu

Study Locations (Sites)

UC San Diego Altman Clinical & Translational Research Institute

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: 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 Date2024-09-09

Study Completion Date2028-01

Study Record Updates

Study Start Date2024-09-09

Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

Type 1 Diabetes