eSupported lifestyle coaching for patients with insulin dependent type 2 diabetes mellitus: a pilot study

Our Western lifestyle plays a large role in the onset and progression of
diabetes-2 (Lim 2011). Insulin resistance has an important role in creating a
vicious circle, where medication needs generally increase over time. Moreover,
increasing blood glucose and insulin levels speed up the processes of weight
gain, insulin resistance, inflammation, aging and comorbidity (like CVD, kidney
failure , cancers, neuropathy and dementia) (Hotamisligl 2010). Hence, reducing
insulin dependence and insulin resistance can be seen as an important
therapeutic goal. This can be achieved with healthy lifestyle improvements.

Several lifestyle interventions have created improved outcomes in type 2
diabetes patients on insulin therapy, most notably: lower blood sugar and lower
medication needs (Jenkins 2008; Esposito 2009). However, these are often highly
controlled interventions and the long term sustainability of behaviors is
limited. The question is: can we do this on a more *Do-It-Yourself* and
eSupported basis? This would have two advantages. First, since behavior
improvements are implemented within patients* lives, it improves the chance of
sustained health behavior (Simons 2013). Second, it is cheaper. Since 2010 the
Health Coach Program has been used to improve lifestyle and metabolic outcomes
(including reduced insulin needs for diabetes-2 patients) via eSupport,
improved self-management and rapidly improved health behaviors (Simons 2010,
Simons 2012). The intervention combines improving health literacy with active
behavior change support.

A personalized diagnosis (i.e. pinpointing the exact physiological problem) can
help increasing the patients* understanding of his or her medical condition and
the appropriate way to improve it, which is likely to promote adherence to
instructions. Several organs can contribute to disruption of (glucose)
metabolism in diabetes type 2 (DeFronzo 2009). Functioning of the three main
organs, pancreas, muscle tissue and liver, can be assessed by measuring glucose
and insulin at 30 min intervals during an oral glucose tolerance test (OGTT)
(Abdul-Ghani 2006). Thus, lifestyle improvement can be personalized, depending
on organ specific dysfunction, delaying or even reversing diabetes progression
(Lim 2011).

Obesity and type 2 diabetes are marked by ectopic fat accumulation in numerous
tissues, e.g. liver and heart, which profoundly impacts on tissue function. In
fact, a pile of evidence indicates that excess liver fat drives systemic
inflammation, insulin resistance and hyperglycemia, and fatty acids in heart
muscle are at the root of diabetic cardiomyopathy. Novel imaging techniques can
accurately and non-invasively quantify tissue triglyceride content and heart
function in vivo.

1. to determine the feasibility and acceptability of an e-supported lifestyle
coaching program and
2. to assess the effects of personalized lifestyle support in patients with
insulin dependent type 2 diabetes mellitus immediately after 12 weeks and after
one year of follow up on:
• Fasting glucose levels, glucose tolerance and medication needs (insulin,
metformin)
• Pancreas, muscle and liver function as reflected by OGTT based
multi-parameter diagnosis
• Quality of life
• Progression/regression of kidney failure
• Liver, pancreas, skeletal muscle, kidney and heart ectopic fat accumulation,
and cardiovascular function

Non-randomized, one arm, pilot 12-week intervention study, with additional
effect measurement at 1 year of follow up.

An extensive eSupported lifestyle program is offered, which combines coach
sessions with electronic dashboarding and self-management, plus electronic
health tips and a digital health quiz game. Intensive coaching is offered for 4
weeks with the purpose of generating self-propelling behaviors and
capabilities. The support in weeks 5-12 is more lightweight, with group session
at the end of weeks 6, 8 and 12, weekly electronic tips and a digital health
game.

As an umbrella overarching the personalized modifications outlined above, the
general lifestyle advice follows the guidelines of the Harvard Epidemiology and
Nutrition Group for nutrition and physical activity, with specific
modifications for diabetics. The guidelines are to increase intake of
vegetables and low sugar fruits (each 2,5 servings/day or more), to choose
whole grains instead of refined grains, to limit sugar and other high glycemic
load foods, to have one daily serving of nuts and/or legumes, to limit intake
of red meat and processed meat, to limit intake of trans and animal fats, and
to have no more than 2 (male) or 1 (female) alcoholic beverages/day. Physical
exercise guidelines are: at least 60 min/day moderate intensity activity (like
walking or gardening) and at least 3x30 min/week intensive activity (Borg level
12-14). Stress management guidelines are: relaxation exercises for >10 min/day.

Supervision of Diabetes Mellitus Type 2 patients in changing the lifestyle is
the most important part of the standard therapy. This study thus is within the
scope of the standard clinical care for the treatment of type 2 Diabetes
Mellitus. The risk associated with participation is limited to the chance of
incidental findings on MRI scan and the risk of lower blood sugars during the
diet and exercise intervention. This risk is minimized by strict glycemic
control, and where necessary, adaptation of the medication. The benefits of
improved glycemic control outweigh the low risk of hypoglycemic events in the
long term .

Successful lifestyle change provides health benefits , lower medication
requirement. Lifestyle change is difficult to adhere to, so that intensive
supervision is needed in order to be successful.