NCT05967260

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-20
• Completion: 2024-09-20
• First posted: 2023-08-01
• Last updated: 2025-05-31
• Results posted: 2025-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study