While type 2 diabetes is generally considered to be a chronic, progressive condition, a recent clinical trial showed that with pharmacist-led therapeutic nutritional intervention, reversal is a realistic goal.
As Sean McKelvey, chief executive officer of the Institute for Personalized Therapeutic Nutrition, told attendees at the 2018 Pharmacy Solutions in Drug Plan Management Forum in Mississauga, Ont. on Sept. 25, health-care professionals have known for 30 years that bariatric surgery can reverse type 2 diabetes in up to 85 per cent of patients. But only in recent years has the impact of other dietary approaches, such as therapeutic nutrition, been considered.
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Therapeutic nutrition is an individually tailored intervention that uses food (through a low carbohydrate and ketogenic diet, for example) instead of, or in conjunction with, medication to target a specific medical condition.
Two years ago, the Institute for Personalized Therapeutic Nutrition undertook a clinical trial in partnership with the University of British Columbia, Pharmasave and other stakeholders to look at the impact of a pharmacist-led therapeutic nutrition intervention on type 2 diabetes.
Specifically, the trial aimed to determine whether a pharmacist-led, low carbohydrate, ketogenic diet could eliminate the need for glucose-lowering medications in people with type 2 diabetes, while its secondary purpose was to improve blood glucose in these individuals, said McKelvey.
“We want to focus in on building a knowledge base, so that we better understand how this can be better utilized by health-care professionals.”
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Researchers worked with 13 community pharmacies in British Columbia to carry out a randomized, controlled trial with 200 participants — 100 in the therapeutic nutrition group and 100 under their regular care.
Pharmacists focused on four key areas: safety, namely avoiding hypoglycemia and hypotension; prioritizing which medications are being reduced; monitoring results; and communication with patients and physicians.
“So, they’re monitoring very closely to make sure that the patient’s being taken care of, they can proactively address any of the medication-related issues that are happening,” said McKelvey.
In addition to assessing eligibility (to participate, the individual had to be diagnosed with type 2 diabetes and be on at least one blood glucose lowering medication), pharmacists were tasked with performing a medication review before starting the trial, ensuring the labs were completed and developing the deprescribing plan to be approved by the physician. Pharmacists then implemented the deprescribing plan, monitored blood glucose, blood pressure and worked to avoid any preventable medication-related adverse events.
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“As a pharmacist service, it has the potential to be very accessible, it also has the potential to be very scalable,” said McKelvey. “So we can start to implement these diabetes deprescribing centres where we can focus in on using these types of therapeutic nutrition interventions.”
According to preliminary results, most patients on insulin were off it within two to three weeks, with 100 per cent off by week 12, noted McKelvey. The average patient in the study was taking 100 units of insulin, and even with this dramatic drop in medications their blood sugars continued to improve.
“That’s where the value of the monitoring of the pharmacist comes in, because we avoid hypoglycemia, we avoid any risks of hyperglycemia as well, so the pharmacists are managing the blood glucose — again this is just using food,” he said.
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“They were taking medications at the start of the trial, they’re off those medications and their blood glucose has normalized. This is not supposed to happen. So this is very exciting; it’s something that I think is going to be the future of health-care services, — physicians, pharmacists, nurses and dietitians are all going to be focusing in on diabetes remission as the key objective.”
In terms of financial impact, a reduction of around 1,200 units of insulin at a cost of approximately $82 day would result in a savings of $2,500 per patient.
Ultimately, McKelvey said, the results point towards a ‘new paradigm’ for the treatment of type 2 diabetes.
“We now have an opportunity, we now have choice for patients, and those choices . . . under most circumstances, those patients are choosing the food intervention over the medications.”
Read more articles from the 2018 Pharmacy Solutions in Drug Plan Management Forum