DailyDose Smart Snack Study for T1D on MDI

NCT05967260 | Completed Results FDA Device

• 1 other identifier: 25174
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Keywords

Decision Support; Dexcom CGM

Outcome Measures

Primary Outcomes (1)

• Probability of Overnight Hypoglycemia

  An episode of overnight hypoglycemia is counted if sensor glucose is \<70 mg/dL for at least two measurements during an eight-hour period following announced bedtime. This is assessed by number of episodes divided by total number of nights.

  8 weeks (4-week control period vs. 4-week intervention period)

Secondary Outcomes (16)

• Time to the First Overnight Low-glucose Event (<70 mg/dL)

  8 weeks (4-week control period vs. 4-week intervention period)

• Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight)

  8 weeks (4-week control period vs. 4-week intervention period)

• Percentage of Time With Sensed Glucose Less Than 54 mg/dL (24-hour/Day Study Duration)

  8 weeks (4-week control period vs. 4-week intervention period)

• Percentage of Time With Sensed Glucose Less Than 70 mg/dL (Overnight)

  8 weeks (4-week control period vs. 4-week intervention period)

• Percentage of Time With Sensed Glucose Less Than 70 mg/dL (24-hour/Day Study Duration)

  8 weeks (4-week control period vs. 4-week intervention period)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Device: DailyDose Smart Snack app

Control

ACTIVE COMPARATOR

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.

Device: Dexcom G6 CGM

Interventions

DailyDose Smart Snack app 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.

Intervention

Dexcom G6 CGM 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.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Results Point of Contact

• Title: Clara Mosquera-Lopez
• Organization: Oregon Health & Science University

mosquera@ohsu.edu

503--418-4129

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: September 1, 2023
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Locations

US (1)