(289 days)
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No
The summary describes a digital therapeutic delivering cognitive behavioral therapy and providing self-reporting and notification features. There is no mention of AI, ML, or any adaptive or learning algorithms in the device description or performance studies.
Yes
The device is described as a "digital therapeutic device" and provides "cognitive behavioral therapy as a treatment" to aid in the management of type 2 diabetes.
No
The device is a digital therapeutic device intended to provide cognitive behavioral therapy to aid in the management of type 2 diabetes by targeting behavior. It focuses on helping users make behavioral modifications and self-report information, but it does not diagnose medical conditions.
Yes
The device description explicitly states that BT-001 is delivered "through an application on the patient's personal Android smartphone" and is "completely self-directed," indicating it is a software application running on a general-purpose computing platform without requiring dedicated medical device hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The description of BT-001 clearly states it's a digital therapeutic device that delivers cognitive behavioral therapy through a smartphone application. It does not involve the analysis of any biological samples like blood, urine, or tissue.
- The intended use is behavioral modification. The device aims to help patients manage their type 2 diabetes by aiding in behavioral changes related to eating habits, nutrition, and exercise. This is a therapeutic intervention, not a diagnostic test.
- The device provides therapy, not diagnostic information. While it allows users to self-report data like blood glucose readings, its primary function is to deliver CBT, not to analyze these readings for diagnostic purposes.
Therefore, BT-001 falls under the category of a digital therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
Product codes
QXC
Device Description
BT-001 is a digital diabetes device that delivers cognitive behavioral therapy (CBT) to a patient with Type 2 Diabetes through an application on the patient's personal Android smartphone. BT-001 is prescription use only and is completely self-directed. The device is designed to allow patients to complete CBT without human support or intervention and is intended to be used in 90-day increments adjunctively to standard of care.
The cognitive behavioral therapy delivered by BT-001 is intended to aid users in making behavioral modifications to better adhere to behaviors associated with the management of diabetes. BT-001 focuses on users understanding barriers to their adhering to known diabetes management behaviors such as eating habits. nutrition, and exercise. The device also provides a way for users to self-report their meals, exercise, medications, and biometrics. When relevant, BT-001 will supply additional notifications for users to contact a healthcare provider, such as when a user logs a blood glucose reading.
This medical device has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this De Novo request, if the product has functions that are not subject to FDA premarket review. FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
The device is a software only device accessible through a user's personal Android smartphone. The software of the device consists of the smartphone application (App), Web Server, and Admin. The App is the user interface for the device and features account management, onboarding, behavioral therapy and program content, biometric entry and tracking, goal setting, and progress visualization, help and support, and user data management. The Web application provides verification of eligibility, registration of their device, and authentication and password retrieval. The Server is a web-based application that provides core functionality to the App and Web via various application programming interfaces (APIs). The Admin is a web-based application that provides administrative functionality for BT-001. Access to the Admin functionality is only available to Administrators of Better Therapeutics.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
18 years or older
Intended User / Care Setting
patients who are under the care of a healthcare provider. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Pivotal Study:
Study Type: Controlled, prospective, multicenter pivotal clinical trial. Randomized Open-Label clinical trial.
Sample Size: The study randomized 726 participants, of whom 668 downloaded their assigned digital app and completed the onboarding process (Control group: 343, BT-001 group: 325).
Objectives:
- The primary objective was to assess the safety and effectiveness of BT-001 as an intervention for type 2 diabetes as measured by a change in HbA1c and the occurrence, relatedness and severity of adverse events after 90 days.
- The secondary objective was to assess the safety and effectiveness of BT-001 after 180 days.
Key Results: - Primary endpoint: difference of control and intervention groups in mean change from baseline of A1c at Day 90 between groups.
- Intention To Treat - Day 90: Control Mean (SD) 0.14 (1.23); BT-001 Mean (SD) -0.27 (1.11). Number of subjects: Control n=313, BT-001 n=297.
- Per Protocol - Day 90: Control Mean (SD) 0.09 (1.16); BT-001 Mean (SD) -0.38 (1.02). Number of subjects: Control n=245, BT-001 n=159.
- Secondary endpoint: difference of control and intervention groups in mean change from baseline of A1c at Day 180 between groups.
- Intention To Treat Day - 180: Control Mean (SD) -0.07 (1.19); BT-001 Mean (SD) -0.37 (1.36). Number of subjects: Control n=271, BT-001 n=244.
- Per Protocol - Day 180: Control Mean (SD) -0.03 (1.11); BT-001 Mean (SD) -0.41 (1.10). Number of subjects: Control n=217, BT-001 n=160.
- Safety Results:
- Treatment-Emergent Adverse Events (TEAE) (Post-Randomization, Days 1-180):
- Control (n=343 subjects): 188 (55%) subjects, 324 events.
- BT-001 (n=325 subjects): 135 (42%) subjects, 265 events.
- Severity of TEAE:
- Mild: Control 117 (34%) subjects / 219 events; BT-001 100 (31%) subjects / 215 events.
- Moderate: Control 55 (16%) subjects / 87 events; BT-001 30 (9%) subjects / 45 events.
- Severe: Control 16 (5%) subjects / 18 events; BT-001 5 (2%) subjects / 5 events.
- Serious TEAE: Control 24 (7%) subjects / 26 events; BT-001 9 (3%) subjects / 9 events.
- Four (4) TEAEs in three subjects were adjudicated to be possibly or probably related to use of BT-001: tachycardia, thirst, pollakiuria, and increasing HbA1c.
- PHQ-9 scores ≥20 (resulting in discontinuation):
- Days 1-90: Control 3, BT-001 1.
- Days 90-180: Control 2, BT-001 1.
- PHQ-9 Positive Question 9 (suicidal ideation):
- Days 1-90: Control 3, BT-001 1.
- Days 90-180: Control 6, BT-001 2.
- Treatment-Emergent Adverse Events (TEAE) (Post-Randomization, Days 1-180):
- Correlation with usage:
- Participants that completed more lessons through device use observed greater reductions in %A1c from baseline.
- At day 90: 0 lessons (n=313) 0.14%, 11 lessons (n=104) -0.45%.
- At day 180: 0 lessons (n=313) -0.07%, 20 lessons (n=87) -0.61%.
- Correlation with additional medical visits:
- Intervention group with additional medical visits observed greater reductions in A1c.
- Change in %A1c (SD) from baseline at days 90 and 180 for ITT and PP populations.
- Additional Medical Visits at day 90 ITT: Control 0.062 (1.16), BT-001 -0.40 (0.95).
- Additional Medical Visits at day 180 ITT: Control -0.07 (1.15), BT-001 -0.38 (1.31).
- No Additional Medical Visits at day 90 ITT: Control 0.27 (1.32), BT-001 -0.05 (1.29).
- No Additional Medical Visits at day 180 ITT: Control 0.17 (1.60), BT-001 0.01 (1.42).
- Additional Medical Visits at day 90 PP: Control 0.05 (1.15), BT-001 -0.51 (0.93).
- Additional Medical Visits at day 180 PP: Control -0.08 (1.08), BT-001 -0.43 (1.13).
- No Additional Medical Visits at day 90 PP: Control 0.19 (1.15), BT-001 -0.09 (1.15).
- No Additional Medical Visits at day 180 PP: Control 0.19 (1.27), BT-001 -0.31 (0.97).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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N/A
0
DE NOVO CLASSIFICATION REQUEST FOR BT-001
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Diabetes digital behavioral therapeutic device. A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.
NEW REGULATION NUMBER: 21 CFR 880.5735
CLASSIFICATION: Class II
PRODUCT CODE: QXC
BACKGROUND
DEVICE NAME: BT-001
SUBMISSION NUMBER: DEN220058
DATE DE NOVO RECEIVED: September 21, 2022
SPONSOR INFORMATION:
Better Therapeutics 548 Market Street, #49404 San Francisco, CA 94104
INDICATIONS FOR USE
The BT-001 is indicated as follows:
BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
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LIMITATIONS
The sale, distribution, and use of BT-001 are restricted to prescription use in accordance with 21 CFR 801.109.
The device is not intended for use as a standalone therapy.
The device is not a substitute for a patient's prescribed therapy or medication.
The device should not be used by people with unstable psychiatric disorders.
The device is not intended for use in the treatment of any psychiatric disorder or symptoms.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
BT-001 is a digital diabetes device that delivers cognitive behavioral therapy (CBT) to a patient with Type 2 Diabetes through an application on the patient's personal Android smartphone. BT-001 is prescription use only and is completely self-directed. The device is designed to allow patients to complete CBT without human support or intervention and is intended to be used in 90-day increments adjunctively to standard of care.
The cognitive behavioral therapy delivered by BT-001 is intended to aid users in making behavioral modifications to better adhere to behaviors associated with the management of diabetes. BT-001 focuses on users understanding barriers to their adhering to known diabetes management behaviors such as eating habits. nutrition, and exercise. The device also provides a way for users to self-report their meals, exercise, medications, and biometrics. When relevant, BT-001 will supply additional notifications for users to contact a healthcare provider, such as when a user logs a blood glucose reading.
This medical device has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this De Novo request, if the product has functions that are not subject to FDA premarket review. FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
SUMMARY OF NONCLINICAL/BENCH STUDIES
SOFTWARE
The device is a software only device accessible through a user's personal Android smartphone. The software of the device consists of the smartphone application (App), Web Server, and Admin. The App is the user interface for the device and features
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account management, onboarding, behavioral therapy and program content, biometric entry and tracking, goal setting, and progress visualization, help and support, and user data management. The Web application provides verification of eligibility, registration of their device, and authentication and password retrieval. The Server is a web-based application that provides core functionality to the App and Web via various application programming interfaces (APIs). The Admin is a web-based application that provides administrative functionality for BT-001. Access to the Admin functionality is only available to Administrators of Better Therapeutics.
All of the elements of software and cybersecurity information as outlined in FDA's guidance documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005) and "Content of Premarket Submissions for management of Cybersecurity in Medical Devices" (issued October 2, 2014) were provided.
PERFORMANCE TESTING - BENCH
Not applicable
PERFORMANCE TESTING - ANIMAL AND/OR CADAVER
Not applicable
SUMMARY OF CLINICAL INFORMATION
Pivotal Study:
The sponsor conducted a controlled, prospective, multicenter pivotal clinical trial consisting of 726 participants where 668 downloaded their assigned digital app and completed the onboarding process. The control group consisted of 343 people with type 2 diabetes who followed their prescribed standard of care therapy and the intervention group consisted of 325 people with type 2 diabetes who used the BT-001 device in addition to their prescribed standard of care therapy. Both groups were allowed to have glycemic control medications changed throughout the study by their healthcare provider.
| Study Feature | Description |
|---|---|
| Title | Open-Label, Randomized, Controlled, Parallel-Group Trial of |
| a Digital Therapeutic for the Treatment of Type 2 Diabetes | |
| Summary | A randomized, open label, controlled trial of 6 months at home |
| BT-001 vs. standard of care (SOC). | |
| Investigational Device | BT-001 |
| Objectives | • The primary objective was to assess the safety and |
| effectiveness of BT-001 as an intervention for type 2 | |
| diabetes as measured by a change in HbA1c and the |
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| | • occurrence, relatedness and severity of adverse events
after 90 days.
• The secondary objective was to assess the safety and
effectiveness of BT-001 after 180 days. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study Design | Randomized Open-Label clinical trial with 343 control
subjects and 325 intervention subjects |
| Number of Sites | Fourteen US clinical sites |
| Population | Eligible subjects were patients aged 18 to 75 years with type 2
diabetes and HbA1c 7.0 - 10.9%. Exclusion criteria included
medical conditions or medications likely to affect HbA1c such
as active eating disorders, prior bariatric surgery, pregnancy,
oral corticosteroids, prandial insulin, weight loss or atypical
antipsychotic medications or Patient Health Questionnaire-9
(PHQ-9) scores ≥ 20 |
| Sample Size | The study randomized 726 participants, of whom 668
downloaded their assigned digital app and completed the
onboarding process (Control group: 343, BT-001 group: 325) |
| Treatment Group | Randomized Trial:
• Intervention Group: BT-001 use and daily biometric
tracking
• Control Group: Standard of Care |
| Study Duration | 6 months total |
| Protocol Overview/Synopsis | • Primary endpoint: difference of control and
intervention groups in mean change from baseline of
A1c at Day 90 between groups
• Secondary endpoint: difference of control and
intervention groups in mean change from baseline of
A1c at Day 180 between groups |
Baseline study demographics are summarized in the table below for the control and intervention (BT-001) groups.
| | Control
n=313 | BT-001
n=297 |
|--------------------------------------|------------------|-----------------|
| Age, years, mean (SD) | 58 (9) | 58 (9) |
| Female, n (%) | 180 (58) | 166 (56) |
| Race, n (%) | | |
| White | 192 (61) | 183 (62) |
| Black or African American | 93 (30) | 89 (30) |
| Asian | 16 (5) | 13 (4) |
| American Indian or Alaskan
Native | 6 (2) | 3 (1) |
4
| Native Hawaiian or another Pacific
| Islander | 2 (1) | 1 (0.3) |
|---|---|---|
| Other (includes multiple races) or | ||
| not reported | 10 (3) | 12 (4) |
| Hispanic or Latino ethnicity, n (%) | 41 (13) | 51 (17) |
| Highest level of education, n (%) | ||
| Less than high school degree | 4 (1) | 2 (1) |
| High school degree or equivalent | 38 (12) | 30 (10) |
| Some college but no degree | 94 (30) | 80 (27) |
| Associate degree | 51 (16) | 51 (17) |
| Bachelor's degree | 74 (24) | 79 (27) |
| Graduate degree | 52 (17) | 55 (19) |
| Median income by ZIP code, $ | 60441 | 64778 |
| Body mass index, kg/m2, mean | ||
| (SD) | 35 (7) | 34 (7) |
| HbA1c %, mean (SD) | 8.1 (0.9) | 8.2 (0.9) |
| Fasting glucose, mg/dL, mean | ||
| (SD) | 168 (55) | 170 (57) |
| Years since diagnosis of diabetes, | ||
| mean (SD) | 11 (8) | 11 (8) |
Study Sample Size
The sample size was calculated assuming a two-sided, two-sample t-test would be used to compare the difference in mean change from baseline in HbA1c between the intervention and control arm assuming a common standard deviation for both groups. The assumed common standard deviation of 1.4% and a clinically significant difference in means of 0.4% were used to determine that a nominal sample size, with 90% power, was 259 subjects per treatment group. However, the Applicant also considered a 20% attrition rate and thus calculated a sample size of 324 subjects per group.
Pivotal Study Safety Results:
Better Therapeutics defined adverse events as follows:
- Any abnormal laboratory test result (e.g., hematology, clinical chemistry, or urinalysis) or . other abnormal safety assessment (e.g., electrocardiogram, radiological scan, vital sign
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measurement), that worsens from baseline and is considered clinically significant in the medical and scientific judgement of the investigator
- . Exacerbation of a chronic or intermittent pre-existing condition, including either an increase in frequency and/or intensity of the condition
- New conditions that are identified or diagnosed after the study treatment was . administered, even if those conditions may have been present prior to the start of the study
- . Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction
- . Signs, symptoms, or the clinical sequelae of a suspected overdose of a concomitant medication. Overdose per se was not reported as an AE or serious adverse event (SAE) unless it was an intentional overdose taken with possible suicidal/self-harming intent. Such overdoses were to be reported regardless of sequelae.
- . "Lack of efficacy" or "failure of expected physiological action" per se were not to be reported as an AE or SAE. Such instances were captured in the efficacy assessments. However, the signs, symptoms, and/or clinical sequelae, resulting from lack of efficacy, were reported as an AE or SAE, if they fulfilled the definition of an AE or SAE
Better Therapeutics defined adverse events that occurred after the onboarding of the study as treatment-emergent adverse events (TEAE).
A summary of the number of subjects with reportable TEAEs observed during the study (postrandomization) is provided in the following table:
| Post - Randomization, Days 1-180 | ||||
|---|---|---|---|---|
| Control | ||||
| n = 343 | BT-001 | |||
| n = 325 | ||||
| Subjects | ||||
| n (%) | Events | |||
| n | Subjects | |||
| n (%) | Events | |||
| n | ||||
| TEAE | 188 (55) | 324 | 135 (42) | 265 |
| Maximum Severity of TEAE | ||||
| Mild | 117 (34) | 219 | 100 (31) | 215 |
| Moderate | 55 (16) | 87 | 30 (9) | 45 |
| Severe | 16 (5) | 18 | 5 (2) | 5 |
| Serious TEAE | 24 (7) | 26 | 9 (3) | 9 |
Table 1. Adverse Events by Study Treatment Group
The sponsor also provided their assessment of TEAEs that were adjudicated as being possibly or probably associated with intervention. The sponsor reported that four (4) TEAEs in three subjects were adjudicated to be possibly or probably related to use of BT-001 during the study. These events included tachycardia, thirst, pollakiuria, and increasing HbA Ic.
PHQ-9 scores were tracked throughout the study to evaluate the risks of worsening depression and suicidal ideation. Participants with scores ≥20 were excluded or discontinued from the study. Table 2 shows PHQ-9 scores that resulted in study discontinuation.
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| | Post - Randomization; Days 1-
90 | | Post - Randomization; Days 90-180 | |
|---------------------------------|-------------------------------------|-------------------|-----------------------------------|-------------------|
| | Control
n = 343 | BT-001
n = 325 | Control
n = 343 | BT-001
n = 325 |
| PHQ-9 ≥20 | 3 | 1 | 2 | 1 |
| PHQ-9
Positive
Question 9 | 3 | 1 | 6 | 2 |
Table 2. PHO-9 scores ≥20 considered severe, and positive to Question 9 indicates suicidal ideation
Pivotal Study Observed Results:
Overall reduction in % A1c (change from baseline) for the control and intervention groups as measured at Day 90 and Day 180 is shown in Table 3 along with standard deviation.
Table 3. Mean (standard deviation) and range (minimum, maximum) %A1c change from baseline for the intention to treat population and the per protocol population in the control and intervention arms.
| Analysis Group and Timepoint
(Initial sample size) | Control
(n=343) | BT-001
(n=325) |
|-------------------------------------------------------|--------------------|-------------------|
| Intention To Treat - Day 90 | | |
| Mean (SD) | 0.14 (1.23) | -0.27 (1.11) |
| (min, max) | (-4.00, 5.95) | (-3.55, 5.50) |
| Number of subjects | n=313 | n=297 |
| Intention To Treat Day - 180 | | |
| Mean (SD) | -0.07 (1.19) | -0.37 (1.36) |
| (min, max) | (-4.20, 3.80) | (-4.40, 5.95) |
| Number of subjects | n=271 | n=244 |
| Per Protocol - Day 90 | | |
| Mean (SD) | 0.09 (1.16) | -0.38 (1.02) |
| (min, max) | (-4.00, 4.90) | (-3.55, 3.70) |
| Number of subjects | n=245 | n=159 |
| Per Protocol - Day 180 | | |
| Mean (SD) | -0.03 (1.11) | -0.41 (1.10) |
| (min, max) | (-4.20, 3.80) | (-3.65, 3.15) |
| Number of subjects | n=217 | n=160 |
For the intervention group the magnitude of A1c reduction was not uniform across the participants. Participants that completed more lessons through device use observed greater reductions in % A 1 c from baseline at both day 90 and day 180. A post-hoc analysis of the data is shown in Table 4 where a range of completed lessons has a corresponding % A1c reduction.
Table 4. Change in %A1c at day 90 and 180 from baseline with more completed lessons from the device
| # Lessons Complete | %A1c Change | Standard Deviation |
|---|---|---|
| -------------------- | ------------- | -------------------- |
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| 0 at day 90; n=313 | 0.14 | 1.23 |
|---|---|---|
| 11 at day 90; n = 104 | -0.45 | 0.86 |
| 0 at day 180; n=313 | -0.07 | 1.19 |
| 20 at day 180; n=87 | -0.61 | 1.14 |
The second variable that correlated with differences in the magnitude of A 1c reduction was whether subjects had additional medical visits outside of the pre-planned visits for the study. The participants in the intervention group who had additional medical visits with a healthcare provider observed greater reductions in Alc compared to intervention group participants who did not have an additional medical visit with a healthcare provider. The data is shown in Table 5 with standard deviations.
| Control | Intervention | |
|---|---|---|
| Additional Medical Visits at day 90 | ||
| ITT | 0.062 (1.16) | |
| n=198 | -0.40 (0.95) | |
| n=189 | ||
| Additional Medical Visits at day 180 | ||
| ITT | -0.07 (1.15) | |
| n=253 | -0.38 (1.31) | |
| n=229 | ||
| No Additional Medical Visits at day 90 | ||
| ITT | 0.27 (1.32) | |
| n=115 | -0.05 (1.29) | |
| n=108 | ||
| No Additional Medical Visits at day 180 | ||
| ITT | 0.17 (1.60) | |
| n=60 | 0.01 (1.42) | |
| n=68 | ||
| Additional Medical Visits at day 90 | ||
| PP | 0.05 (1.15) | |
| n=159 | -0.51 (0.93) | |
| n=109 | ||
| Additional Medical Visits at day 180 | ||
| PP | -0.08 (1.08) | |
| n=182 | -0.43 (1.13) | |
| n=132 | ||
| No Additional Medical Visits at day 90 | ||
| PP | 0.19 (1.15) | |
| n=86 | -0.09 (1.15) | |
| n=50 | ||
| No Additional Medical Visits at day 180 | ||
| PP | 0.19 (1.27) | |
| n=35 | -0.31 (0.97) | |
| n=28 |
Table 5. Change in % A1c (standard deviation) from baseline at days 90 and 180 for the Intention To Treat (ITT) and Per Protocol (PP) populations
Pediatric Extrapolation:
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
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Device labeling includes the device indications for use, a description of the device, warnings and precautions, a summary of the clinical testing with the device, and instructions for use of the device. The labeling is sufficient and satisfies the requirements of 21 CFR 801.109 Prescription Devices.
Per the special controls for this generic type of device, labeling includes a summary of the clinical testing with the device and certain limiting statements. The labeling includes the following statements to meet the special controls:
- . The device is not intended for use as a standalone therapy.
- . The device is not a substitute for a patient's prescribed therapy or medication.
- . The device should not be used by people with unstable psychiatric disorders.
- The device is not intended for use in the treatment of any psychiatric disorder or . symptoms.
- . Among those assigned to the device, the average change in %HbA Ic observed in the clinical study was -0.27 compared to baseline after 90 days, and -0.37% compared to baseline after 180 days.
- After 90 days of device use, while 179 patients (60%) saw numerically improved ー :: glycemic control (%HbA1c decreased compared to baseline), there were 118 patients (40%) who saw no change or numerically worsened glycemic control (%HbA1c increased compared to baseline). In comparison, 136 patients (43%) in the control group saw HbA1c improvement and 177 (57%) saw no change or worsened glycemic control. These differences between the device and control group were statistically significant (p20.
BENEFIT/RISK CONCLUSION
In conclusion, given the available information above, for the following indication statement:
BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
The probable benefits outweigh the probable risks for the BT-001 device. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the BT-001 is granted and the device is classified as follows:
Product Code: QXC Device Type: Diabetes digital behavioral therapeutic device Regulation Number: 21 CFR 880.5735 Class: II