Type 1 Diabetes Mellitus With Hypoglycemia
Conditions
Keywords
Decision Support, Dexcom CGM
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.
Interventions
DEVICEDailyDose 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.
DEVICEDexcom 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.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Overnight Hypoglycemia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | 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 to the First Overnight Low-glucose Event (<70 mg/dL) | 8 weeks (4-week control period vs. 4-week intervention period) | Number of hours until first CGM measurement \<70 mg/dL when CGM remains \< 70 mg/dL for at least 10 minutes. |
| Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | 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) | 8 weeks (4-week control period vs. 4-week intervention period) | Assess the mean reported sensor glucose values overnight (announced bedtime + 8 hours) using the Dexcom sensor. |
| Mean Sensed Glucose (24-hour/Day Study Duration) | 8 weeks (4-week control period vs. 4-week intervention period) | 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 | 4 weeks of control period | 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 | 4 weeks of control period | 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 | 8 weeks (4-week control period vs. 4-week intervention period) | Asses mean weight change from start to end of each arm. |
| Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (24-hour/Day Study Duration) | 8 weeks (4-week control period vs. 4-week intervention period) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control to Intervention The randomization order for participants in this arm was Dexcom G6 CGM (control) followed by DailyDose Smart Snack (intervention). Each arm was 4 weeks long. | 10 |
| Intervention to Control The randomization order for participants in this arm was DailyDose Smart Snack (intervention) followed by Dexcom G6 CGM (control). Each arm was 4 weeks long. | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Arm Start-up Visit (4 Weeks) | Dexcom CGM failed while participant out of town without ability to receive a replacement | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention to Control | Total | Control to Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 19 Participants | 9 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 15.1 | 39 years STANDARD_DEVIATION 14.7 | 41.2 years STANDARD_DEVIATION 14.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 16 Participants | 9 Participants |
| Region of Enrollment United States | 11 participants | 21 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Probability of Overnight Hypoglycemia | 23.6 percentage of nights | Standard Deviation 15.6 |
| Control | Probability of Overnight Hypoglycemia | 26.0 percentage of nights | Standard Deviation 14.1 |
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.
Time frame: 4 weeks of control period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Accuracy of Overnight Low Glucose Prediction by Sensitivity | 71.6 percentage of true positive events |
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.
Time frame: 4 weeks of control period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Accuracy of Overnight Low Glucose Prediction by Specificity | 56.8 percentage of true negative events |
Secondary
Change in Weight
Asses mean weight change from start to end of each arm.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Weight | -2.1 kg | Standard Deviation 3 |
| Control | Change in Weight | -0.7 kg | Standard Deviation 1.3 |
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Mean Sensed Glucose (24-hour/Day Study Duration) | 161.9 mg/dL | Standard Deviation 24.2 |
| Control | Mean Sensed Glucose (24-hour/Day Study Duration) | 165.2 mg/dL | Standard Deviation 27.3 |
Secondary
Mean Sensed Glucose (Overnight)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Mean Sensed Glucose (Overnight) | 159.0 mg/dL | Standard Deviation 25.1 |
| Control | Mean Sensed Glucose (Overnight) | 160.4 mg/dL | Standard Deviation 26.5 |
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time Sensed Glucose Greater Than 250 mg/dL (24-hour/Day Study Duration) | 10.4 percentage of time | Standard Deviation 9.5 |
| Control | Percentage of Time Sensed Glucose Greater Than 250 mg/dL (24-hour/Day Study Duration) | 11.3 percentage of time | Standard Deviation 10.8 |
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).
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight) | 10.2 percentage of time | Standard Deviation 8.9 |
| Control | Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight) | 9.7 percentage of time | Standard Deviation 9 |
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Between 70-180 mg/dL (24-hour/Day Study Duration) | 63.9 percentage of time | Standard Deviation 14.9 |
| Control | Percentage of Time With Sensed Glucose Between 70-180 mg/dL (24-hour/Day Study Duration) | 61.4 percentage of time | Standard Deviation 16.5 |
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).
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Between 70-180 mg/dL (Overnight) | 64.0 percentage of time | Standard Deviation 14.4 |
| Control | Percentage of Time With Sensed Glucose Between 70-180 mg/dL (Overnight) | 61.8 percentage of time | Standard Deviation 14.8 |
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (24-hour/Day Study Duration) | 32.8 percentage of time | Standard Deviation 15.3 |
| Control | Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (24-hour/Day Study Duration) | 35.5 percentage of time | Standard Deviation 16.6 |
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).
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (Overnight) | 31.7 percentage of time | Standard Deviation 15.6 |
| Control | Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (Overnight) | 33.5 percentage of time | Standard Deviation 16.1 |
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Less Than 54 mg/dL (24-hour/Day Study Duration) | 0.7 percentage of time | Standard Deviation 0.7 |
| Control | Percentage of Time With Sensed Glucose Less Than 54 mg/dL (24-hour/Day Study Duration) | 0.7 percentage of time | Standard Deviation 1 |
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).
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight) | 1.0 percentage of time | Standard Deviation 1.5 |
| Control | Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight) | 1.3 percentage of time | Standard Deviation 3.2 |
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Less Than 70 mg/dL (24-hour/Day Study Duration) | 3.2 percentage of time | Standard Deviation 1.8 |
| Control | Percentage of Time With Sensed Glucose Less Than 70 mg/dL (24-hour/Day Study Duration) | 3.1 percentage of time | Standard Deviation 2.3 |
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).
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage of Time With Sensed Glucose Less Than 70 mg/dL (Overnight) | 4.2 percentage of time | Standard Deviation 3.8 |
| Control | Percentage of Time With Sensed Glucose Less Than 70 mg/dL (Overnight) | 4.7 percentage of time | Standard Deviation 5.5 |
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.
Time frame: 8 weeks (4-week control period vs. 4-week intervention period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Time to the First Overnight Low-glucose Event (<70 mg/dL) | 2.8 hours | Standard Deviation 1.4 |
| Control | Time to the First Overnight Low-glucose Event (<70 mg/dL) | 3.3 hours | Standard Deviation 1.4 |