SMART
BYTE
®
DEVICE
USER GUIDE
Rx Only
Caution:
Federal law restricts this Device to sale
by or on the order of a physician.
Read this information completely before
using your SmartByte
®
device.
1. Indications for Use
The SmartByte Device is intended to aid in weight management in overweight
to obese individuals. The Device is indicated for individuals with a body
mass index (BMI) in the range 27-35 kg/m
2
in conjunction with behavioral
modification instruction.
2. Description of the SmartByte Device
The SmartByte Device is intended to be used by overweight to obese
individuals. Overweight means a body mass index (BMI) in the range of 27-
29.9 kg/m
2
. Obese means a BMI in the range of 30-35 kg/m
2
.
The SmartByte Device will be made specifically for you to take up space in the
upper palate (the roof) of your mouth. The Device will be made from a mold of
your palate taken by a trained healthcare provider using the Palatal Mold Kit
component of the Device in your healthcare practitioner’s office. The SmartByte
Device should be worn during meals. The Device is designed to limit bite
size and reduce the amount of food or caloric liquid consumed. The Device is
available with wire clasps or wrap-around wires to position the Device in the
mouth
(Figure 1)
. The
parts
that occupy the space in your mouth (pink and
clear parts in the pictures below) are the same.
Figure 1: SmartByte Device and Temperature Sensor
SmartByte Devices using the positioning clasp method (left) and wraparound method (right)
The SmartByte Device is made of acrylic. The soft edges are made of Silident
polymers. The clasps and wraparound wires are made of Elgiloy (a type of
flexible metal material).
The SmartByte Device contains a small sensor that measures and records
environmental conditions (such as temperature) at 5 minute intervals and
stores the data for up to 56 days. The sensor detects when the Device has
been inserted in your mouth. If you wish to use the optional SmartByte Reader
component, you will be able to track your actual Device usage.
If you desire, your healthcare provider and/or support group can also see your
progress. The SmartByte Reader is described below.
The sensor is operated by a small 3-volt coin battery. The battery and the
SmartByte Device have a life span of 1.2 years. The battery and sensor are
both sealed in the Device and cannot be replaced. The only purpose of the
sensor is to monitor Device usage. As noted above and discussed below,
optional components (SmartByte case / reader, iPhone or Android phone app
that can be downloaded) are available with the Device to upload and view the
sensor data. The data provide feedback and graphs on how often you use the
Device.
3. Contraindications, Warnings and Precautions
Contraindications
Eating Disorder:
Do not use the Device if you have eating disorders (such as
anorexia nervosa (abnormally low body weight, intense fear of gaining weight,
and distorted perception of body weight), bulimia nervosa (eat large amounts
of food and then purge (e.g., vomit) to not gain weight). The Device is a weight
management aid and is contraindicated (means do not use) in individuals with
eating disorders. There may be safety risks if you have an eating disorder and
use this Device.
Pregnancy:
Do not use the Device if you are pregnant. The Device is a weight
management aid and weight loss is contraindicated (means do not use) in
pregnancy. There may be safety risks if you are pregnant and use this Device.
Warnings
Hot Liquid/Food Hazard:
Test the temperature of any hot liquids or foods
before drinking or eating while using the SmartByte Device. As you normally
would when you are eating (without using the SmartByte Device), make sure
the liquid or food is at a comfortable temperature for you to drink or eat. This
may be different temperatures for different people. Do not swallow the liquid
or food without sensing the temperature first. The SmartByte Device covers the
roof of your mouth. Once the Device is in your mouth, you may not be able to
sense the temperature of liquid or food before swallowing.
Removal at Night:
Do not sleep with this Device in your mouth as it may
cause breathing difficulties. The Device is intended to be used only during
eating or drinking (caloric beverages).
Precautions
Gag Reflex:
Ask your physician for help to see if you have a sensitive gag
reflex. If you do, you may not be a good candidate to use this Device.
Get Used to Your Device:
Take some time to get used to the feel of the Device
in your mouth. You may need time to adapt to using the Device (having the
Device in your mouth when eating or drinking).
Wear Only When Eating or Drinking Caloric Beverages:
Remove the Device
when finished eating or drinking. The SmartByte Device is intended to be
placed in the mouth only during eating, including meals, snacks, and drinking
calorie-containing beverages.
Taking Small Bites:
Take small bites of food. Since you will have less space
in your mouth when the SmartByte Device is in place, you will want to take
small bites of food. If you take large bites, you might need to take some food
out of your mouth, or you might choke or gag on the food when trying to chew
or swallow.
Loose Fit:
Make sure the Device feels like it fits properly and is in place in
your mouth before you eat or drink. You should not feel the Device moving
or wobbling in your mouth. Do not attempt to eat if the Device is loose when
inserted, and contact your healthcare professional who prescribed the Device
for you. The healthcare professional will arrange for the manufacturer or its
representative to examine and, if necessary, replace or repair your Device.
Biting Down with Device in Place:
You do not need to take any action if
you feel contact with the Device when biting down. However, if a piece of
the Device becomes loose (such as wobbling or falls out of place) or breaks
off, stop using the Device. Your healthcare professional will arrange for the
manufacturer to examine, and if necessary, replace or repair your SmartByte
Device.
Individuals with a BMI <27 and BMI >35:
Do not use if your BMI is <27 or >
35 kg/ m
2
. The SmartByte Device has not been studied in these individuals.
Oral Health:
Do not use the SmartByte Device if you have not had a dental
examination within the last 12 months. Do not use the Device if you are not in
good oral health. You should follow up with your dentist regularly to maintain
oral health.
Conditions in the Oral Cavity:
Do not use the SmartByte Device and tell your
prescribing healthcare professional if you have any of the following conditions
(or develop any of these conditions):
• Deformed oral shape (e.g., bony protrusion on palate or prior surgery such
that Device cannot sit flush against the palate)
• Removable partial dentures (false teeth) in your upper arch (roof of mouth)
• Inadequate oral anatomy (e.g., 3 or more loose or missing teeth on the
upper arch, molars or pre-molars either missing or worn down to within
4 mm above gum line, teeth with too much curvature that make placing
and removing the Device difficult, an ore-nasal fistula (hole connecting
the mouth and the nasal cavity) secondary to cleft palate, or a large torus
palatinus (bony growth or protruding part on the palate))
• Veneers (a thin covering for the front surface of a tooth)
• Temporary crowns (tooth-shaped cap that is placed over a tooth)
• Placement of dental implants within 12 months of Device use
• In the process of having teeth moved or have completed a tooth moving
procedure in the past 6 months and use any removable retainer Device
(e.g., retainers, or aligner trays)
• Removable or fixed bridges (replacements of missing teeth attached to the
neighboring teeth or implant)
The SmartByte Device has not been studied in patients with these conditions.
Patients with these conditions may not be able to properly use the SmartByte
Device.
Other conditions:
Tell your prescribing healthcare professional before using
the SmartByte Device if you have or had the following conditions, or if you
develop any of these conditions after you start using the Device:
• Neurological disease or condition(s) (e.g., history of stroke, or other
diseases that cause problems swallowing);
• Diabetes;
• Current smoker or user of smokeless tobacco or nicotine gum; or
• Sjogren’s syndrome (immune system disorder that causes dry mouth) or
chronic dry mouth.
The SmartByte Device has not been studied in patients with these conditions.
There might be more risks for these patients if they use the SmartByte Device.
Risks and Benefits
The discussion provided below describes results from clinical studies
conducted by Scientific Intake (SI). The pivotal study was the larger study of
the Device. The confirmatory study included fewer subjects and was intended
to confirm the findings from the larger pivotal study.
3.1. Pivotal Study
The SmartByte Device was tested in a clinical study in the United States.
The study evaluated if the SmartByte Device is safe and helps weight
management in 173 overweight to obese individuals. The study looked at
people with body mass index [BMI] between 26 to 36 kg/m
2
. The study
compared the weight loss between SmartByte Device users and control
subjects (who did not use the SmartByte Device) after four months. Few
SmartByte Device users had adverse events (negative side effects) related
to the Device.
Study subjects were randomly assigned (like ‘drawing straws’) to either the
SmartByte Device group or a control group. Device group users received
a SmartByte Device plus nutrition, diet and exercise counseling on a DVD.
The control group did not receive a SmartByte Device and received only
the same nutrition, diet and exercise counseling on a DVD. The information
contained on this DVD included guidelines for healthy eating and exercise.
The DVD also includes information about realistic weight loss goals and
the importance of personal and professional support systems for subjects.
Subjects were evaluated in the 16-week study (or 4 months) every two
weeks. During visits to the clinical site, subjects were weighed, had vital
signs taken, and watched the counseling video. Any adverse events were
recorded. For SmartByte Device subjects, the amount that the Device was
used was also recorded.
SmartByte Device and control subjects were similar, including in age,
gender, ethnic background, height, weight, and BMI.
The safety results are shown below for the full study population: 102
subjects in the Device group and 71 in the control group. The full study
population includes subjects who followed the protocol as well as those
who did not use the Device as often as instructed or did not attend at least
4 of the 7 study visits. The weight loss results are shown for the full study
population, as well as for the subgroup of subjects who followed the study
protocol during the 4-month study. Subjects who followed the protocol (41
in the Device group and 67 in the control group) included subjects who used
the Device during at least one-third (33%) of meals, and went to at least 4
of the 7 follow-up visits. The control subjects had to attend at least 4 of 7
visits to be considered to have followed the protocol.
Of the 173 subjects enrolled in the study, 65 subjects (61 Device subjects
and 4 control subjects) did not use the Device as instructed, did not follow
the protocol, or did not finish the study/attend enough visits. Subjects who
used the SmartByte Device were supposed to wear the Device when eating
any food and drinking any caloric liquid. Subjects in the control group did
not use any Device, and only had to go to the clinic visits every 2 weeks and
watch the DVD.
3.1.1 Safety
Few Device-related adverse events happened during the study. There were
a total of 6 minor adverse events in 5 of the 102 subjects who used the
SmartByte Device.
The minor adverse events reported included gum irritation in 2 subjects.
There was soreness in mouth in 1 subject. One subject reported “gag
reflex” (gagging when placing the Device in the mouth). Two subjects
reported temporary choking on food. These events were not serious, and
went away quickly without medical treatment.
3.1.2. Effectiveness
The benefits of the SmartByte Device were tested in a clinical study in the
United States. The data demonstrated significantly more weight loss with
the SmartByte Device compared to the control groups at the end of four
months. Results measured the subjects’ total body weight loss compared to
their body weight at baseline.
In the full study population, including those who did not use the Device as
often as instructed or attended less than 4 of the 7 study visits, the average
weight loss in the SmartByte Device group (102 subjects) was 1.65%
compared to 0.36% in the control group (71 subjects). For the subjects who
followed the protocol, the average total body weight loss in the SmartByte
Device group (41 subjects) was 4.39% compared to 0.29% in the control
group (67 subjects). Therefore, 4.39% total body weight loss in a subject
who weighs 200 lbs. at baseline would translate to a weight loss of 8.8 lbs.
with the SmartByte Device.
3.2. Confirmatory Study
Another clinical study was conducted in the United States to study the
SmartByte Device in overweight to obese individuals whose body mass
index [BMI] measured 27 to 35 kg/m
2
. All of the study subjects received
the SmartByte Device plus weight loss counseling using a DVD. The DVD
used in this study was the same used for the pivotal study. Subjects were
evaluated in the 16-week study once every 2 weeks. During study visits,
subjects were weighed and checked for adverse events, viewed the
counseling DVD, and had a physical examination. All subjects received the
SmartByte Device. The data for how often they used the Device was also
uploaded from the Device to the health care provider’s computer during
the visit. The study encouraged subjects to follow the protocol. The study
emphasized that the subject needs to use the Device often to help weight
loss. There was a screening period before subjects were qualified to join the
study to make sure that he or she was motivated to lose weight. Subjects
were not paid based on their amount of weight loss.
Study subjects were 20 to 49 years old and had an average BMI of 31.70
kg/m
2
before starting to use the SmartByte Device. The subject received
the wraparound or side clasps version of the SmartByte Device based
on evaluation of the subject’s oral anatomy. These two versions are very
similar, and the safety and weight loss results were also similar.
Data about how effective the SmartByte Device is to help weight loss were
collected. The full study population consisted of 76 subjects all in the Device
group. The full study population includes subjects who followed the protocol
as well as those who did not use the Device as often as instructed or did
not complete the last study visit. The weight loss results are shown for the
full study population, as well as for the subgroup of subjects who followed
the study protocol during the study. Subjects who followed the protocol
(40 of the 76 subjects) included subjects who used the Device at least 7
times per week for at least 14 of the 16 weeks of the study, during at least
one-third (33%) of eating episodes, and completed the last study visit at
week 16. This use rate is lower than recommended for clinical testing
purposes. You should use the Device during all meals and when drinking
caloric beverages to maximize potential benefit from using the Device. The
safety results are from all 76 subjects who received the SmartByte Device.
Nine (9) of these 76 subjects did not complete the study due to withdrawal
of consent (n=7), lost to follow up (n=1), and adverse event (pregnancy)
(n=1). None of their reasons for leaving the study were due to safety events
related to the SmartByte Device.
3.2.1. Effectiveness
As described below, the results of this study were similar to those reported
in the other study (described above). Subjects who used the Device as
instructed showed a consistent rate of weight loss over the 16-week period,
and more weight loss on average compared to the full study population.
On average, the full study population lost 2.05% of their total body weight
by the end of the study. Subjects in this group lost an average of 3.75 lbs.
(range 9.9 lbs. weight gain to 19.4 lbs. weight loss) from their baseline
weight. The subjects who followed the protocol lost 2.93% of their total
body weight at the end of the study. Subjects in this group lost an average
of 5.2 lbs. (range 9.9 lbs. weight gain to 18.7 lbs. weight loss) from their
baseline weight.
How much weight subjects lost depended on how often they used the
Device. For example, the 17 subjects who used the Device for 15 or more
times per week lost an average of 6.5 pounds. The 47 subjects who used
the Device for 7-14 times per week lost an average of 3.1 pounds (including
the 16 subjects who showed no weight change or gained weight). The 12
subjects who used the Device for 0-6 times per week lost an average of 2.5
pounds (including the 7 subjects who showed no weight change or gained
weight).
Weight loss increased over time for those who used the Device as
instructed. Subjects who used the Device as instructed for 1 month lost 1.9
lbs., for 2 months lost 2.1 lbs., for 3 months lost 3.2 lbs., and for 4 months
lost 5.2 lbs. on average compared to their weight at baseline (before using
the Device).
3.2.2. Safety
Few adverse events occurred during the study that were considered to be
related to the Device. These events, one hard palate abrasion event (Device
scratching the roof of the mouth) and two tongue laceration events (Device
scratching the tongue), were not considered to be serious, and resolved
during the study without any medical treatment. A few additional adverse
events happened in the study that were not considered to be related to use
of the SmartByte Device.
3.3. Risks of Device Use
The risks of using the Device, based on the events seen in the studies
described above, are presented in Table 1. No unexpected risks were
reported in the studies. Some of the risks below may be prevented by
following the instructions in this manual and from your healthcare provider.
However, there may be some risks with correct Device use too. Although
some of these hazards were reported only for the older version of the
Device, they may be potential risks of using the SmartByte Device.
Table 1: Risks of Device Use
Hazard
Subjects
with Hazard
Harm/Potential Harm
Affected
Subjects
Loose fit of Device
16 of 178
subjects
Needed new Device
16
Device worn down
or bending*
11 of 178
subjects
Needed new Device
11
Soft edge
separation**
15 of 178
subjects
Needed new Device
15
Wire felt upon biting
8 of 178
subjects
Needed new Device
8
Acrylic, ball clasp,
or other breakage*
7 of 178
subjects
Needed new Device
7
Device lost
7 of 178
subjects
Needed new Device
7
Reaction to Device†
6 of 178
subjects
Gag reflex upon
insertion of the Device
1
Choked on food while
using Device
2
Gum irritation
2
Soreness in mouth
1
Food caught in Device
5 of 178
subjects
Needed new Device
2
Hard palate abrasion;
temporarily suspended
use of the Device
1
Tongue laceration
(scratched)
2
Uncomfortable fit
of Device
3 of 178
subjects
Needed new Device
3
Device retained
food flavor of previous
meal
2 of 178
subjects
Needed new Device
2
Device damaged by
study subject or
third party
2 of 178
subjects
Needed new Device
2
Difficult removal
1 of 178
subjects
Needed new Device
1
* Reported in pivotal study
** Reported in confirmatory study
† These reactions resolved without medication, and the subjects were able
to continue the study.
The information in the table above is based on the first 4 months of the
study. It is unknown what adverse events may develop after 4 months and
how many subjects may develop them. In these studies, we did not observe
some adverse events we thought were possible. It is not known the possible
harm from these types of events or how often they might happen (for
example, with longer use or more widespread use). In addition, there may
be other risks that are not known yet.
Most of the Devices lasted throughout the clinical studies. The few Devices
that showed breakage or separation were of the older Device design.
For example, soft edge separation was reported for 15 subjects in the
Sensor
Positioning Clasp
Wraparound
