Back to resultsDailyDose Smart Snack Study for T1D on MDI
Primary Purpose
Type 1 Diabetes Mellitus With Hypoglycemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DailyDose Smart Snack app
Dexcom G6 CGM
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus With Hypoglycemia focused on measuring Decision Support, Dexcom CGM
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
Sites / Locations
- Oregon Health and Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
Mean sensed glucose (overnight)
Assess the mean reported sensor glucose values overnight (announced bedtime + 8 hours) using the Dexcom sensor.
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.
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.
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.
Change in weight
Asses mean weight change from start to end of each arm.
Full Information
NCT ID
NCT05967260
First Posted
July 21, 2023
Last Updated
September 6, 2023
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT05967260
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus With Hypoglycemia
Keywords
Decision Support, Dexcom CGM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DailyDose Smart Snack app
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dexcom G6 CGM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Probability of overnight hypoglycemia
Description
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.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Secondary Outcome Measure Information:
Title
Time to the first overnight low-glucose event (<70 mg/dL)
Description
Number of hours until first CGM measurement <70 mg/dL when CGM remains < 70 mg/dL for at least 10 minutes.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose less than 54 mg/dL (overnight)
Description
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).
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose less than 54 mg/dL (24-hour/day study duration)
Description
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.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose less than 70 mg/dL (overnight)
Description
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).
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose less than 70 mg/dL (24-hour/day study duration)
Description
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.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose between 70-180 mg/dL (overnight)
Description
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).
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose between 70-180 mg/dL (24-hour/day study duration)
Description
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.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose greater than 180 mg/dL (overnight)
Description
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).
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time with sensed glucose greater than 180 mg/dL (24-hour/day study duration)
Description
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.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time sensed glucose greater than 250 mg/dL (overnight)
Description
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).
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Percentage of time sensed glucose greater than 250 mg/dL (24-hour/day study duration)
Description
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.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Mean sensed glucose (overnight)
Description
Assess the mean reported sensor glucose values overnight (announced bedtime + 8 hours) using the Dexcom sensor.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Mean sensed glucose (24-hour/day study duration)
Description
Assess the mean reported sensor glucose values across the full 24-hour/day study duration using the Dexcom sensor.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
Title
Accuracy of overnight low glucose prediction by sensitivity
Description
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.
Time Frame
4 weeks of control period
Title
Accuracy of overnight low glucose prediction by specificity
Description
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.
Time Frame
4 weeks of control period
Title
Change in weight
Description
Asses mean weight change from start to end of each arm.
Time Frame
8 weeks (4-week control period vs. 4-week intervention period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara Mosquera-Lopez, PhD
Phone
503-418-9331
Email
mosquera@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Branigan
Phone
15034189070
Email
branigad@ohsu.edu
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Branigan
Phone
503-418-9070
Email
branigad@ohsu.edu
12. IPD Sharing Statement
Learn more about this trial
DailyDose Smart Snack Study for T1D on MDI
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