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DailyDose Smart Snack Study for T1D on MDI

NCT05967260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-05-31

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-09-20
Completion
2024-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967260 on ClinicalTrials.gov