Miriam E Tucker

September 28, 2015

STOCKHOLM — The use of insulin pumps in patients with difficult-to-treat type 2 diabetes is safe and effective for up to 5 years, a small single-center study suggests.

The findings were presented September 17 here at the European Association for the Study of Diabetes (EASD) 2015 Meeting by Priyamvada Singh, MD, of St Vincent Hospital, Worcester, Massachusetts.

"Insulin pumps can act as a valuable new treatment option, especially for those individuals failing on current injection regimens," Dr Singh said, noting that about 30% of patients with type 2 diabetes are not well controlled despite multiple daily injections of basal and bolus insulins.

A previous randomized, controlled trial, Medtronic's OPT2MISE of 331 patients who had not responded to multiple daily basal-bolus injection regimens, showed a 0.7-percentage-point improvement in HbA1c among those in the insulin-pump group (P < .00001).

But that study lasted only 6 months. The current study was very small, with just 13 patients, but it is the longest reported experience to date of the use of insulin pumps in people with type 2 diabetes, Dr Singh noted, adding that the lack of good long-term data is one reason that insurance companies have been reluctant to cover insulin-pump therapy in type 2 patients (although some do).

Session moderator Johan G Eriksson, MD, professor of medicine at the University of Helsinki, Finland, told Medscape Medical News, "I believe myself in pump treatment for type 2 diabetic patients, especially if they need very high insulin doses, so I think it's really one alternative that could be used more frequently."

Dr Eriksson, who was on the EASD program committee and helped choose this particular abstract for presentation, said that despite the study's small size, "we thought it was interesting, something that should cause discussion. Five years is a long time."

However, he added, "It's also an issue of cost. We're not that keen on starting type 2 patients on pumps in Europe."

Improvement Seen in HbA1c with Pump Use

The study was a retrospective single-center chart review of 13 adults (10 men, three women) with a mean age 55 years (range, 43–71) and mean body mass index 34.5 kg/m2. They were not well controlled (HbA1c >7%) on insulin alone (n=11) or insulin plus metformin (n=2).

Study subjects also had to have one or more of the following problems with insulin therapy: daily dose more than 200 units, more than four injections per day, wide glycemic excursions, and/or intractable hypoglycemia.

All were taught how to count carbohydrates and to use the "bolus wizard" feature of the Medtronic pump, which automatically calculates the premeal bolus dose of insulin based on insulin-to-carb ratios and "correction" adjustments for highs or lows manually entered into the pump's software.

A single endocrinologist adjusted the patients' pump settings every 1 to 2 weeks for the first 2 months, after which the patients performed the adjustments themselves but were encouraged to follow up with staff every 2 to 3 months.

At 5 years, the average HbA1c for the group had dropped to 7.7% from an average 8.9% at baseline, a large statistically significant difference (P = 0.0076).

In one notable case, a patient's HbA1c dropped from 10.5% to 6.6%. Another patient, the one with the highest HbA1c at 5 years, 9.0%, had also started off with the highest value, 10.8%.

The group gained a small amount of weight, from 235 pounds at baseline to 243 pounds at 5 years. But basal insulin requirements didn't change much, from 102.5 to 103.3 units, and postmeal glycemic excursions were reduced.

There were minor hypoglycemic episodes in three patients, none requiring hospitalization.

The nine of 13 who answered a patient satisfaction questionnaire scaled at 1 (poor) to 5 (excellent), gave average scores of 4 or higher for questions related to physical health (work and physical activity), social activity, and insulin-pump performance compared with multiple daily injections.

"This patient population [had been] very frustrated because they had tried everything.…Most of them were very happy," Dr Singh commented.

Start Small and Build Up

She acknowledged that the small study size was a limitation but pointed out that "in medical science, when we don't have a consensus on something we start with small studies and then try to replicate with bigger studies."

Cost-effectiveness of pumps for type 2 diabetes patients in different healthcare systems still needs to be evaluated, she advised, noting that the pumps themselves cost between $4500 and $6500, not including the disposable supplies that can add thousands more annually.

"We need more studies to support and more experience to back this up so that insurance will [cover] it and more people can take advantage of it," Dr Singh said.

Dr Eriksson pointed out that if such trials show that use of insulin pumps in type 2 patients allow for a reduction in insulin dose — not shown in this trial, but there was a significant dose reduction in OPT2MISE — the cost equation might turn out to be beneficial.

"If you calculate the prices, you could find out after all it's not that expensive."

Dr Singh has no relevant financial relationships. Dr Eriksson consults and/or gives lectures for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, and AstraZeneca.

European Association for the Study of Diabetes 2015 Meeting; Stockholm, Sweden. Abstract 155, presented September 17, 2015.


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