Status:
COMPLETED
DailyDose Smart Snack Study for T1D on MDI
Lead Sponsor:
Oregon Health and Science University
Conditions:
Type 1 Diabetes Mellitus With Hypoglycemia
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This is a single-center, open-label, crossover trial with two arms and two periods (2x2) and one-week washout period. The study is designed to evaluate the efficacy of an AI-based bedtime smart snack ...
Detailed Description
Participants will be randomized to either first use CGM only to manage glucose for four weeks (control arm) followed by four weeks of DailyDose App + bedtime smart snack intervention (intervention arm...
Eligibility Criteria
Inclusion
- Diagnosis of type 1 diabetes mellitus for at least 1 year
- Male or female participants 18 years of age or older
- Using multiple daily injections
- HbA1c \<10% at screening
- Current use of a continuous glucose monitoring system with at least two episodes of overnight hypoglycemia (defined as sensed glucose \<70 mg/dL for at least 10 minutes between the hours of 10 PM and 6 AM) within 30 days prior to screening
- Individuals with history of severe hypoglycemia requiring third party assistance must have a companion in the same dwelling as the study participant who will be linked to the participant's Dexcom app during the control arm of the study, and who is trained in the administration of glucagon.
- Willingness to follow all study procedures
- Willingness to sign informed consent and HIPAA documents
Exclusion
- Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence
- Any active infection
- Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use)
- Seizure disorder
- Use of non-insulin glucose lowering medications
- Use of steroids
- Stage-three or more advanced chronic kidney disease
- Hypo- or hyper- thyroidism that is not medically optimized and on a stable regimen define as Thyroid-stimulating hormone (TSH) outside of the normal reference range based on screening labs
- Adrenal insufficiency
- Cirrhosis
- Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol
- Individual working night shifts
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05967260
Start Date
September 1 2023
End Date
September 20 2024
Last Update
May 31 2025
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239