NCT05967260Completed
DailyDose Smart Snack Study for T1D on MDI
A Crossover Study to Assess the Effect of an Artificial Intelligence (AI)-Based Bedtime Smart Snack Intervention in Preventing Overnight Low Glucose in People With T1D on Multiple Daily Injections.
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
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 intervention in reducing nocturnal low glucose in people living with T1D on MDI therapy compared with traditional CGM-augmented MDI therapy as the control.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 21 Jul 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 20 Sept 2024
- Lead sponsor
- Oregon Health and Science University
- Diseases
- Type 1 diabetes
- NCT number
- NCT05967260
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 1 Sept 2023 to the primary completion date, 20 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use)
- Use of steroids
Other illness
- Any active infection
- Seizure disorder
- Stage-three or more advanced chronic kidney disease
- Adrenal insufficiency
- 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
Lab values
- Use of non-insulin glucose lowering medications
Other
- 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
- 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
- Cirrhosis
- Individual working night shifts
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.