Benefits of Continuous Glucose Monitoring With GEM Lifestyle Modification for Adults With Type 2 Diabetes

Type 2 diabetes (t2d) is a major epidemic of the developing world which has huge fiscal
consequences and many physical complications. It is thought to be brought on in part by
contemporary easy access to high energy foods and reduced physical activity, resulting in
increased belly fat that culminates in growing insulin resistance and subsequent
hyperglycemia. Because of ease and efficacy of medication management, t2d is primarily
managed with ever-escalating medication use, which significantly contributes to medical cost
and possibly the progression of the disease itself.

An effective supplement or alternative to medication management is lifestyle modification.
Conventional lifestyle modification focuses on reducing body fat and insulin resistance
through weight reduction from caloric restriction and aerobic exercise. Sustained routine
application of this approach is limited because some individuals do not need to lose weight,
some do not want to lose weight, others cannot lose weight, and when successful, lifelong
weight reduction is difficult to sustain. A useful paradigm shift in lifestyle treatment of
t2d might be to go from reducing calories to reducing postprandial glucose (PPG), the primary
contributor to glycosylated hemoglobin (HbA1c).

PPG spikes can be prevented by replacing high with low glycemic load foods and dampened by
engaging in postprandial physical activity. This is exemplified by the integrated Glycemic
load, Exercise and Monitoring glucose (GEM) program. It promotes choices of low glycemic load
foods and increased physical activity, directed by glucose monitoring feedback. Glucose
feedback can: 1) educate people as to what food choices minimize PPG and what physical
activity choices directly lower PPG, 2) activate individuals when glucose is out of their
desired range by alerting them to make choices to lower high glucose or raise low glucose,
and 3) motivate individuals to repeat those choices that resulted in desirable glucose
consequences. The educating, activating and motivating benefits of glucose feedback are
thought to be qualitatively and quantitatively enhanced through continuous glucose monitoring
(CGM).

It is hypothesized that, compared to Routine Care (RC), GEM with CGM (GEM+CGM) administered
to adults with t2d who are failing with oral medication management will result in better
diabetes control (lower HbA1c), reduced medication management (less medication), and better
psychological functioning (e.g. greater sense of empowerment) in the short term (3 month
follow-up). Further, it is hypothesized that their reduction in HbA1c will be driven by a
reduction in PPG.

Inclusion Criteria:

- Type 2 diabetes

- Between the ages of 21 and 80

- Failed on an oral medication regimen (HbA1c > 7.5%).

Exclusion Criteria:

- Takes insulin

- Took medications in the last 3 months that impede weight loss (e.g., prednisone)

- Pregnant or contemplating pregnancy in the next 12 months

- Conditions that preclude increasing physical activity (e.g. severe neuropathy,
cardiovascular disease, chronic obstructive pulmonary disease/emphysema,
osteoarthritis, stroke)

- Severe mental disease (e.g. manic depressive illness, severe depression, or active
substance abuse)

- Undergoing treatment for cancer

- History of lactic acidosis

- Marked renal impairment (eGFR < 45; stage 3b chronic kidney disease)

- Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)

- Cannot read English.