NEW ORLEANS—Diabetic patients appear to be proficient at using a mobile, handheld electronic diary that enables effective remote patient monitoring during intensive insulin titration.

This finding, presented here at the 69th Scientific Sessions of the American Diabetes Association (ADA), demonstrated that patients with type 1 or type 2 diabetes were highly adherent and accurate when using the mobile device to relay critical information to their physicians.

“One of the barriers to intensive insulin therapy is that patients and physicians are worried about the higher risk of hypoglycemia when a patient’s insulin dose is increased,” said lead investigator Marcia A. Testa, MPH, PhD, Senior Lecturer on Biostatistics at the Harvard School of Public Health in Boston.

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She noted that “by enabling [physicians] to carefully watch the health outcomes of their patients in real time during intensive insulin therapy, hyper- and hypoglycemic episodes might be reduced and even averted. Patients also have greater peace of mind knowing that their nurse or physician is watching over their diabetes self-management decisions.”  

For the multicenter trial, investigators assessed patient adherence and accuracy when recording and transmitting blood glucose (BG), insulin dose, symptom, and health status data during six months of intensive insulin titration in 51 type 1 and 269 type 2 patients.

“Long-term clinical trials have demonstrated that intensive therapy to control hyperglycemia decreases microvascular and some macrovascular complications in patients with type 1 and 2 diabetes,” stated study co-author Donald C. Simonson, MD, MBA, MPH, ScD, Lecturer on Medicine at Harvard Medical School in Boston.

“The incidence of type 2 diabetes is increasing, and most type 2 patients will eventually need insulin to achieve target hemoglobin A1c (HbA1c) levels. However, current statistics show that less than half of patients currently using insulin therapy achieve the ADA-recommended HbA1c level of 7% or less. Achieving target recommendations has been very difficult since the success of diabetes management requires day-to-day decisions, and in the usual care setting, we only see patients a few times a year.”

Titrating insulin requires frequent office visits and telephone calls, which can be very resource-intensive, but this new remote monitoring technology allows physicians to be there “virtually” for the patient on a daily basis during the critical early phases of intensive insulin titration.

Dr. Testa noted that the program’s success can, in part, be explained by the fact that the entire process was made extremely simple for both patients and their clinicians. “We had a very diverse population from 50 clinical centers throughout the United States, so the technology had to be fairly widely accepted,” she said.

Here is how the technology, developed in conjunction with Phase V Technologies, Inc., of Wellesley Hills, Mass., works: Patients transmit data daily from a handheld device that serves as an electronic journal. The device is equipped with a wireless acoustic modem that works with a standard telephone. The patient places the device next to the handset and is prompted to dial a toll-free number. Transmission takes one to two minutes per day.

Physicians and nurses check Web-based data reports via the Internet several times a week and titrate insulin doses weekly using prespecified algorithms.

Overall, 220,098 BG entries were transmitted during a 24-week study period, indicating a 97% adherence rate with the prescribed four-point testing schedule. At 24 weeks, the mean HbA1c level had decreased from 7.8 to 7.0.

The analysis also showed 148,773 recorded insulin dose entries, which is 100% of the anticipated prescribed number.

BG data provided by the electronic journal had a “near perfect” match with data obtained by standard glucose meters.

Patients completed a twice-weekly symptom and health status checklist about 75% of the time.