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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First Overnight Low-glucose Event (<70 mg/dL) | Number of hours until first CGM measurement <70 mg/dL when CGM remains < 70 mg/dL for at least 10 minutes. | 8 weeks (4-week control period vs. 4-week intervention period) |
| Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control to Intervention | The randomization order for participants in this arm was Dexcom G6 CGM (control) followed by DailyDose Smart Snack (intervention). Each arm was 4 weeks long. |
| FG001 | Intervention to Control | The randomization order for participants in this arm was DailyDose Smart Snack (intervention) followed by Dexcom G6 CGM (control). Each arm was 4 weeks long. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Rest Period (1-12 Weeks) |
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| First Arm Start-up Visit (4 Weeks) |
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| Second Rest Period (1-4 Weeks) |
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| Second Arm Start-up Visit |
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| Third Rest Period (1-2 Weeks) |
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| Study Completion Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control to Intervention | The randomization order for participants in this arm was Dexcom G6 CGM (control) followed by DailyDose Smart Snack (intervention). Each arm was 4 weeks long. |
| BG001 | Intervention to Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of nights | 8 weeks (4-week control period vs. 4-week intervention period) |
|
Up to 8 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clara Mosquera-Lopez | Oregon Health & Science University | 503--418-4129 | mosquera@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2024 | Dec 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2024 | May 13, 2025 | ICF_002.pdf |
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| 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. |
|
Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 54 mg/dL overnight (announced bedtime + 8 hours). |
| 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) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 54 mg/dL across the full 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) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 70 mg/dL overnight (announced bedtime + 8 hours). | 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) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 70 mg/dL across the 24-hour/day study duration. | 8 weeks (4-week control period vs. 4-week intervention period) |
| Percentage of Time With Sensed Glucose Between 70-180 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are between 70 and 180 mg/dL overnight (announced bedtime + 8 hours). | 8 weeks (4-week control period vs. 4-week intervention period) |
| Percentage of Time With Sensed Glucose Between 70-180 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are between 70 and 180 mg/dL across the full 24-hour/day study duration. | 8 weeks (4-week control period vs. 4-week intervention period) |
| Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 180 mg/dL overnight (announced bedtime + 8 hours). | 8 weeks (4-week control period vs. 4-week intervention period) |
| Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 180 mg/dL across the full 24-hour/day study duration. | 8 weeks (4-week control period vs. 4-week intervention period) |
| Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 250 mg/dL overnight (announced bedtime + 8 hours). | 8 weeks (4-week control period vs. 4-week intervention period) |
| Percentage of Time Sensed Glucose Greater Than 250 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 250 mg/dL across the full 24-hour/day study duration. | 8 weeks (4-week control period vs. 4-week intervention period) |
| Mean Sensed Glucose (Overnight) | Assess the mean reported sensor glucose values overnight (announced bedtime + 8 hours) using the Dexcom sensor. | 8 weeks (4-week control period vs. 4-week intervention period) |
| Mean Sensed Glucose (24-hour/Day Study Duration) | Assess the mean reported sensor glucose values across the full 24-hour/day study duration using the Dexcom sensor. | 8 weeks (4-week control period vs. 4-week intervention period) |
| Accuracy of Overnight Low Glucose Prediction by Sensitivity | Assessment of accuracy of the overnight low glucose prediction algorithm by sensitivity. This is measured by the number of true positives that the algorithm predicts hypoglycemia overnight divided by all of the hypoglycemic events. | 4 weeks of control period |
| Accuracy of Overnight Low Glucose Prediction by Specificity | Assessment of accuracy of the overnight low glucose prediction algorithm by specificity. This is measured by calculating 1.0 minus the false positive rate for overnight hypoglycemia prediction. | 4 weeks of control period |
| Change in Weight | Asses mean weight change from start to end of each arm. | 8 weeks (4-week control period vs. 4-week intervention period) |
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The randomization order for participants in this arm was DailyDose Smart Snack (intervention) followed by Dexcom G6 CGM (control). Each arm was 4 weeks long.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. 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. |
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| Secondary | Time to the First Overnight Low-glucose Event (<70 mg/dL) | Number of hours until first CGM measurement <70 mg/dL when CGM remains < 70 mg/dL for at least 10 minutes. | Posted | Mean | Standard Deviation | hours | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 54 mg/dL overnight (announced bedtime + 8 hours). | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Less Than 54 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 54 mg/dL across the full 24-hour/day study duration. | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Less Than 70 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 70 mg/dL overnight (announced bedtime + 8 hours). | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Less Than 70 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are less than 70 mg/dL across the 24-hour/day study duration. | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Between 70-180 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are between 70 and 180 mg/dL overnight (announced bedtime + 8 hours). | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Between 70-180 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are between 70 and 180 mg/dL across the full 24-hour/day study duration. | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 180 mg/dL overnight (announced bedtime + 8 hours). | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 180 mg/dL across the full 24-hour/day study duration. | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 250 mg/dL overnight (announced bedtime + 8 hours). | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Percentage of Time Sensed Glucose Greater Than 250 mg/dL (24-hour/Day Study Duration) | Assess the mean percentage of time that the Dexcom G6 reported sensor glucose values are greater than 250 mg/dL across the full 24-hour/day study duration. | Posted | Mean | Standard Deviation | percentage of time | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Mean Sensed Glucose (Overnight) | Assess the mean reported sensor glucose values overnight (announced bedtime + 8 hours) using the Dexcom sensor. | Posted | Mean | Standard Deviation | mg/dL | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Mean Sensed Glucose (24-hour/Day Study Duration) | Assess the mean reported sensor glucose values across the full 24-hour/day study duration using the Dexcom sensor. | Posted | Mean | Standard Deviation | mg/dL | 8 weeks (4-week control period vs. 4-week intervention period) |
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| Secondary | Accuracy of Overnight Low Glucose Prediction by Sensitivity | Assessment of accuracy of the overnight low glucose prediction algorithm by sensitivity. This is measured by the number of true positives that the algorithm predicts hypoglycemia overnight divided by all of the hypoglycemic events. | Posted | Number | percentage of true positive events | 4 weeks of control period |
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| Secondary | Accuracy of Overnight Low Glucose Prediction by Specificity | Assessment of accuracy of the overnight low glucose prediction algorithm by specificity. This is measured by calculating 1.0 minus the false positive rate for overnight hypoglycemia prediction. | Posted | Number | percentage of true negative events | 4 weeks of control period |
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| Secondary | Change in Weight | Asses mean weight change from start to end of each arm. | Posted | Mean | Standard Deviation | kg | 8 weeks (4-week control period vs. 4-week intervention period) |
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| 20 |
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| 20 |
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| 20 |
| EG001 | 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 | 20 | 0 | 20 | 1 | 20 |
| Acute sinusitis | Infections and infestations | Non-systematic Assessment |
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