DailyDose Smart Snack Study for T1D on MDI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Type 1 Diabetes Mellitus With Hypoglycemia

Intervention / Treatment
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* Device: DailyDose Smart Snack app
* Device: Dexcom G6 CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| Active Comparator: Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Support, Dexcom CGM