DailyDose Smart Snack Study for T1D on MDI

Type 1 Diabetes Mellitus With Hypoglycemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967260
• Other study ID #: 25174
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Oregon Health and Science University
• Contact: Clara Mosquera-Lopez, PhD
• Phone: 503-418-9331
• Email: mosquera[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus With Hypoglycemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks (4-week control period vs. 4-week intervention period)
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.	8 weeks (4-week control period vs. 4-week intervention period)
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).	8 weeks (4-week control period vs. 4-week intervention period)
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.	8 weeks (4-week control period vs. 4-week intervention period)
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).	8 weeks (4-week control period vs. 4-week intervention period)
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.	8 weeks (4-week control period vs. 4-week intervention period)
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).	8 weeks (4-week control period vs. 4-week intervention period)
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.	8 weeks (4-week control period vs. 4-week intervention period)
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).	8 weeks (4-week control period vs. 4-week intervention period)
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.	8 weeks (4-week control period vs. 4-week intervention period)
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).	8 weeks (4-week control period vs. 4-week intervention period)
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.	8 weeks (4-week control period vs. 4-week intervention period)
Secondary	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)
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.	8 weeks (4-week control period vs. 4-week intervention period)
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.	4 weeks of control period
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.	4 weeks of control period
Secondary	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)