Remission of type 2 diabetes in shift workers through a personalized lifestyle intervention.

BACKGROUND
In the Netherlands, 1.2 million people are diagnosed with diabetes (5.0% of the
Dutch population). This number increases by 1200 every week. Type 2 diabetes
(T2D) is by far (90%) the most prevalent type. Of the total workforce, 2.0% has
diabetes.

Diabetes has profound consequences for society and patients. On societal level
healthcare costs are rising while patients cope with diabetes-related
consequences such as cardiovascular problems, eye, kidney and nerve diseases
but also depression. Additionally, workers with diabetes are at higher risk for
sickness absence and reduced productivity.

In addition to an unhealthy lifestyle shift work increases the risk of (the
onset) of T2D. This could be explained by three mechanisms:
1. Rotating shifts, including evening and night shift, disturbs the circadian
rhythm which influences the metabolic system;
2. Sleep deprivation (also an effect of rotating shifts) negatively affects
glucose response;
3. Shiftwork is related to an unhealthy lifestyle, e.g. unhealthy eating, lack
of exercise, stress. About 14% of the Dutch workforce is engaged in shift work
and this percentage is increasing rapidly.

Despite the risks of shift work very few general lifestyle interventions and no
personalized lifestyle interventions have been tailored to shift workers or
this type of work setting.

LIFESTYLE INTERVENTIONS
Over the past 20 years, a large number of the developed T2D interventions
focused on lifestyle instead of pharmacotherapy, targeting the metabolic
dysregulation rather than the symptoms. Already in 2002, the Diabetes
Prevention Program demonstrated that both medication (metformin) and healthy
lifestyle effectively reduced T2D biomarkers. However, lifestyle changes proved
to be more efficient compared to medication.
TNO developed a personalized intervention program, including the subtyping of
T2D, which aims to reverse and, if possible, cure T2D using lifestyle. The
treatment program consists of a combination of proven-effective interventions
in healthcare and the living environment of patients. The program starts with
an extensive *360 degree* diagnosis to map the largest bottlenecks (physical-
or mental health, lifestyle, medication, financial situation, social
environment) for an individual. The 360-degree diagnosis also includes the
*diabetyping* or subtyping of T2D. This consists of an Oral Glucose Tolerance
Test (OGTT), based on which it can be determined which organs are insulin
resistant and to what extent the pancreas can still produce insulin. This
information is used to generate personalized dietary and exercise
interventions. TNO used the OGTT, diabetes subtyping and similar lifestyle
advice before in the P4 Hillegom pilot. The research protocol was approved by
the METC Brabant (NL48742.028.14).

Results of the 360-degree diagnosis will be presented in a so-called *profile
wheel*. This wheel aims to support the occupational physician and the patient
in getting a good overview of the patient regarding his or her lifestyle. The
profile wheel is an interactive, visual representation of the core components
which are; body (e.g. glucose, cholesterol, blood pressure, and weight), think
& feel (e.g. experienced health, stress, problems with T2D), behavior (mainly
lifestyle) and environment (financial-, relational-, or housing problems). The
advice is recorded in goals on which the patient can work.

TNO aims to implement this treatment program in an occupational health setting.
This is considered a crucial step in treatment of T2D among shift workers. This
study is a pilot to assess the feasibility of implementation of the program in
occupational healthcare services.

The primary objective is to addapt the lifestyle program to shift workers,
taking their specific preferences, their response to behavioral change
techniques and work demands into account. The feasibility of implementation in
occupational healthcare services will also be assessed. This includes the
assessment of user-experiences (both caregivers and shift workers with T2D) and
the identification of bottlenecks.

The secondary objective is to determine to which extend the lifestyle program
contributes to improved health status in shift workers with T2D, based on
improvements in OGTT response profiles, body weight and use of medication.

This study will be designed as an exploratory implementation study regarding
the feasibility of the lifestyle program in an occupational healthcare services
setting. The work context at Tata Steel in IJmuiden will act as the first field
lab for implementation. The study has two phases, this allows for the
elimination of possible start-up issues in the lifestyle program and
implementation thereof during the first phase. In this first phase, the
lifestyle program will be modified to suit the specific work settings at Tata
Steel and its shift workers with T2D. This phase will result in a small-scale
pilot including six participating shift workers with T2D who will test the
lifestyle program. Participants will be recruited by the occupational health
physician.

Based on the 360-degree diagnosis (questionnaires, health data, OGTT) and a
consult with the occupational health physician in which the profile wheel is
discussed, the participants will receive personalized lifestyle advice. During
the 13-week intervention period, participants will be adviced and supported by
their occupational health physician, a dietician and, depending on the T2D
subtype, a physiotherapist. Together with these healthcare providers, the
participant turns the advice into an action plan including goals. After 13
weeks, results of a second OGTT and the questionnaires will reveal insight into
the progression.

The intervention lasts a total of 13 weeks and consists of 2 parts 1)
360-degree diagnosis, and 2) personalized lifestyle interventions.
First, the "360-degree" diagnosis is performed based on health markers and
questionnaires to map the largest physical and/or mental bottlenecks for an
individual. The 360-degree diagnosis also includes the subtyping of diabetes
type 2. This consist of an Oral Glucose Tolerance Test (OGTT) that provides
insight into the organ function of an individual with type 2 diabetes. Based on
the OGTT six T2D subtypes can be distinguished.

Furthermore, results of the 360-degree diagnosis are displayed in a "profile
wheel". This profile wheel supports the occupational health physician and the
participant in developing a personalized lifestyle action plan. Which dietary
intervention is recommended to a T2D patient is personalized based on their
diabetes subtype. The possible dietary interventions include a Mediterranean
diet, a low carbohydrate diet, a low-calorie diet or intermittent fasting. In
close cooperation with the involved dietician, these four dietary patterns will
be adjusted to the specific work context (physical demands and working in
shifts) at Tata Steel. The dietician will support and coach all participants in
adhering to their selected dietary pattern.

Based on their diabetes subtype participants may also be recommended to
increase their physical activity. The possible training programs include
strength training, endurance training or a combination of these two. A
physiotherapist will provide the participant with a fitting exercise plan,
based on their condition and capabilities. The physiotherapist will support and
coach the participant in compliance with the training program.

Using the profile wheel, the advice is further concretized and recorded in
goals on which the participant can work during the pilot phase.

The risks associated with participation can be considered negligible and the
burden can be considered minimal. There are no expected risks related to the
consults. All medical activities, including blood sampling, will only be
performed by professionals. There are no expected risks (nor benefits) related
to consuming the standardized glucose solution. A potential risk is a nausea
after consumption of the glucose solution. Benefits include that participants
can get more insight into their individual health status and their behavior.
Additionally, participants are provided with more personalized lifestyle advice
and professional support in adhering to this advice; this can help participants
improve their health status and potentially reverse their T2D.