RECRUITING

InsuLearn Feasibility with Type 1 Diabetes Patients Under MDI Therapy

Conditions

Type 1 Diabetes Mellitus InPen Dexcom CGM

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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 24-hour, randomized, crossover, single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care (UC) intervention. In the InsuLearn intervention, insulin doses are optimized using data collected in a 4-weeks at home data collection period.

Official Title

Feasibility of a Bolus Calculator Without Carbohydrate Counting in Type 1 Diabetes Patients Under Multiple Daily Injections (MDI) Therapy: a Supervised Randomized Controlled Trial.

Quick Facts

Study Start:2025-02-15

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06411548

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 Criteria	Exclusion Criteria
1. Age ≥18.0 years old at time of consent. 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year. 3. Hemoglobin A1c (HbA1c) between 7.0% - 10.0%. 4. Currently using insulin under multiple daily injections (MDI) therapy for at least six months. 5. Poor carbohydrate counting, based on their score on the AdultCarbQuiz (a score lower of 33/43). 6. Willingness to wear the study continuous glucose monitor (CGM) during the duration of the study. 7. Access to the internet and willingness to upload data during the study as needed. 8. 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. 9. Investigator has confidence that the subject can successfully operate all study devices and can adhere to the protocol. 1. NPH (neutral protamine hagedorn) insulin 2. Use of any medication that at the discretion of the investigator is deemed to interfere with the trial. 3. Currently being treated for a seizure disorder. 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: 1. Inpatient psychiatric treatment in the past 6 months 2. Presence of a known adrenal disorder 3. Abnormal liver function test results (Transaminase \>3 times the upper limit of normal) 4. Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2). 5. Active gastroparesis requiring medical therapy. 6. Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L). 7. Abuse of alcohol or recreational drugs 8. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection). 9. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg). 10. Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months. 5. Currently pregnant or intent to become pregnant during the trial. 6. Currently breastfeeding. 7. An injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol. 8. Participation in another pharmaceutical or device trial at the time of enrolment or during the study. 9. Currently taking non-insulin glucose-lowering agent during the trial (including GLP-1 receptor agonists, pramlintide, and SGLT2 inhibitors	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Age ≥18.0 years old at time of consent.
2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year.
3. Hemoglobin A1c (HbA1c) between 7.0% - 10.0%.
4. Currently using insulin under multiple daily injections (MDI) therapy for at least six months.
5. Poor carbohydrate counting, based on their score on the AdultCarbQuiz (a score lower of 33/43).
6. Willingness to wear the study continuous glucose monitor (CGM) during the duration of the study.
7. Access to the internet and willingness to upload data during the study as needed.
8. 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.
9. Investigator has confidence that the subject can successfully operate all study devices and can adhere to the protocol.
1. NPH (neutral protamine hagedorn) insulin
2. Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
3. Currently being treated for a seizure disorder.
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:
1. Inpatient psychiatric treatment in the past 6 months
2. Presence of a known adrenal disorder
3. Abnormal liver function test results (Transaminase \>3 times the upper limit of normal)
4. Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2).
5. Active gastroparesis requiring medical therapy.
6. Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L).
7. Abuse of alcohol or recreational drugs
8. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
9. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg).
10. Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months.
5. Currently pregnant or intent to become pregnant during the trial.
6. Currently breastfeeding.
7. An injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol.
8. Participation in another pharmaceutical or device trial at the time of enrolment or during the study.
9. Currently taking non-insulin glucose-lowering agent during the trial (including GLP-1 receptor agonists, pramlintide, and SGLT2 inhibitors

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Viola Holmes, RD, CDCES

CONTACT

(434) 249-6251

vjf7j@uvahealth.org

Sara Prince, RN

CONTACT

434-320-5599

sp4sa@uvahealth.org

Principal Investigator

Anas Fathi, PhD

PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Study Locations (Sites)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903-2981

United States

Collaborators and Investigators

Sponsor: University of Virginia

Anas 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 Date2025-02-15

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2025-02-15

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

InPen
Dexcom CGM

Additional Relevant MeSH Terms

Type 1 Diabetes Mellitus