DailyDose Smart Snack Study for T1D on MDI

NCT ID: NCT05967260

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-20

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 intervention in reducing nocturnal low glucose in people living with T1D on MDI therapy compared with traditional CGM-augmented MDI therapy as the control.

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), or vice-versa. There will be a one-week washout period between arms.

During the control arm, participants will wear CGM and will manage their glucose as usual. Participants will be asked to wear a smart watch overnight to collect sleep metrics, weigh themselves weekly in the morning before eating, and answer a one-item sleep quality scale survey weekly. We will collect CGM measurements during the control arm for evaluation of effect of intervention and assessment of the accuracy of low glucose prediction.

During the intervention arm, participants will use the DailyDose Smart Snack smart phone app. When they are getting ready for bed, an AI-based model in DailyDose will predict the likelihood of overnight low glucose at bedtime and will recommend a personalized snack to help avoid nocturnal hypoglycemia. The nutritional content of the snack (carbohydrate, protein, fat, etc.) will be dependent on the predicted overnight minimum glucose and the predicted time of the minimum overnight glucose level. During this arm, participants will also be asked to wear a smart watch overnight, weigh themselves weekly, and answer a one-item sleep quality scale survey weekly.

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Participants will use the DailyDose Smart Snack smart phone application which contains an AI-based model that predicts the likelihood of overnight low glucose at bedtime every night and will recommend a personalized snack to help avoid nocturnal hypoglycemia. The nutritional content of the snack (carbohydrate, protein, fat, etc.) will be dependent on the predicted overnight minimum glucose and the predicted time of the minimum overnight glucose level. During this arm, participants will also be asked to wear a smart watch overnight, weigh themselves weekly, and answer a one-item sleep quality scale survey weekly.

Group Type: EXPERIMENTAL

DailyDose Smart Snack app

Intervention Type: DEVICE

A decision support tool that predicts the likelihood of overnight low blood sugar based on current CGM and inputted exercise. App will recommend a snack at bedtime based on the minimum low glucose predicted and the time of the low glucose.

Control

Participants will wear Dexcom G6 CGM and will manage their glucose as usual. Participants will be asked to wear a smart watch overnight to collect sleep metrics, weigh themselves weekly in the morning before eating, and answer a one-item sleep quality scale survey weekly.

Group Type: ACTIVE_COMPARATOR

Dexcom G6 CGM

Intervention Type: DEVICE

A commercially available Continuous Glucose Monitoring system that utilizes a transmitter and sensor to measure sensor glucose levels that transmit to a smart phone app.

Interventions

DailyDose Smart Snack app

A decision support tool that predicts the likelihood of overnight low blood sugar based on current CGM and inputted exercise. App will recommend a snack at bedtime based on the minimum low glucose predicted and the time of the low glucose.

Intervention Type: DEVICE

Dexcom G6 CGM

A commercially available Continuous Glucose Monitoring system that utilizes a transmitter and sensor to measure sensor glucose levels that transmit to a smart phone app.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Clara Mosquera-Lopez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

25174

Identifier Type: -

Identifier Source: org_study_id