Clinical trial NCT05967260: DailyDose Smart Snack Study for T1D on MDI
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus With Hypoglycemia
Keywords: Decision Support
Dexcom CGM
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Probability of Overnight Hypoglycemia
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
Secondary outcomes:
measure: Time to the First Overnight Low-glucose Event (<70 mg/dL)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Less Than 54 mg/dL (24-hour/Day Study Duration)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Less Than 70 mg/dL (Overnight)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Less Than 70 mg/dL (24-hour/Day Study Duration)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Between 70-180 mg/dL (Overnight)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Between 70-180 mg/dL (24-hour/Day Study Duration)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (Overnight)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (24-hour/Day Study Duration)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Percentage of Time Sensed Glucose Greater Than 250 mg/dL (24-hour/Day Study Duration)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Mean Sensed Glucose (Overnight)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Mean Sensed Glucose (24-hour/Day Study Duration)
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
measure: Accuracy of Overnight Low Glucose Prediction by Sensitivity
timeFrame: 4 weeks of control period
measure: Accuracy of Overnight Low Glucose Prediction by Specificity
timeFrame: 4 weeks of control period
measure: Change in Weight
timeFrame: 8 weeks (4-week control period vs. 4-week intervention period)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References: