Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:06 AM
Ignite Modification Date: 2025-12-26 @ 12:32 AM
NCT ID: NCT05967260
Description: All participants that began/started the first rest period after randomization are included in the adverse events. The numbers from the participant flow indicate that 21 subjects began the first rest period.
Frequency Threshold: 0
Time Frame: Up to 8 weeks
Study: NCT05967260
Study Brief: DailyDose Smart Snack Study for T1D on MDI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Comparator: 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. 0 None 0 20 1 20 View
Experimental: 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. 0 None 0 20 1 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View