Type 1 Diabetes Mellitus With HypoglycemiaNCT05967260
DailyDose Smart Snack Study for T1D on MDI
A study testing DailyDose Smart Snack app and Dexcom G6 CGM in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by Oregon Health and Science University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Hypoglycemia
- What is being tested?
- DailyDose Smart Snack app and Dexcom G6 CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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.
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.
Read the 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.
- Being tested
- DailyDose Smart Snack app, Dexcom G6 CGM
- Keywords
- Decision Support, Dexcom CGM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DailyDose Smart Snack appDevice
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 CGMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DailyDose Smart Snack app |
| 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. Receives: Device: Dexcom G6 CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks (4-week control period vs. 4-week intervention period)
Secondary outcomes (16)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks of control period
Change in Weight
Asses mean weight change from start to end of each arm.
Measured: 8 weeks (4-week control period vs. 4-week intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2023
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes Mellitus With HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Mosquera-Lopez, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967260
- Sponsor's protocol ID
- 25174
- Status last verified
- May 2025
- First submitted
- 21 Jul 2023
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05967260
- Acronym / sponsor ID
- 25174
- Keywords
- Decision Support, Dexcom CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: DailyDose Smart Snack appParticipants 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. |
| Control | Active comparator | Device: Dexcom G6 CGMParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DailyDose Smart Snack appA 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. | Device | Intervention |
| Dexcom G6 CGMA commercially available Continuous Glucose Monitoring system that utilizes a transmitter and sensor to measure sensor glucose levels that transmit to a smart phone app. | Device | Control |
Primary outcome
Probability of Overnight Hypoglycemia
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
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.
16 secondary outcomes
Time to the First Overnight Low-glucose Event (<70 mg/dL)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight)
Time frame: 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)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Percentage of Time With Sensed Glucose Less Than 70 mg/dL (Overnight)
Time frame: 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)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Percentage of Time With Sensed Glucose Between 70-180 mg/dL (Overnight)
Time frame: 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)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (Overnight)
Time frame: 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)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight)
Time frame: 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)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Mean Sensed Glucose (Overnight)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Mean Sensed Glucose (24-hour/Day Study Duration)
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Accuracy of Overnight Low Glucose Prediction by Sensitivity
Time frame: 4 weeks of control period
Accuracy of Overnight Low Glucose Prediction by Specificity
Time frame: 4 weeks of control period
Change in Weight
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 1 Diabetes Mellitus With Hypoglycemia
Recruiting
Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
Diabetes (DM), Diabetes Mellitus
Not yet recruitingPhase 1/2
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
Diabete Mellitus, Diabete Type 1
RecruitingPhase 1/2
Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
Diabetes Mellitus, Type 1
Active, not recruitingPhase 1/2
Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D)
Type 1 Diabetes Mellitus
RecruitingPhase 3
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DailyDose Smart Snack app and Dexcom G6 CGM in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of Overnight Hypoglycemia (time frame: 8 weeks (4-week control period vs. 4-week intervention period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.