A telemedicine solution for patients with poorly controlled type 1 diabetes

This trial evaluated the effect of a smartphone-supported software called “Diabeo” on blood sugar levels in patients with poorly controlled Type 1 diabetes (T1DM).

People with T1DM cannot produce insulin, a hormone needed for moving glucose (a simple sugar formed from the food we eat) into body cells. Lack of insulin causes hyperglycemia (too much glucose in the blood, because glucose builds up if it cannot enter the cells). These patients must take insulin by injection.

The effect of treatment is judged by measuring hemoglobin A1c or HbA1c (a test that reveals the average glucose level over the previous three months or so). Management of blood glucose is known as ‘glycemic control’.

Each insulin dose has to be adjusted to various factors, such as pre-meal blood sugar. Too much insulin may cause hypoglycemia (too little glucose in the blood) whereas too little insulin will not achieve adequate glycemic control.

The Diabeo software enables individualized insulin dose adjustments combined with telemedicine support: It utilizes patient-reported glucose levels, or ‘self monitoring plasma glucose measurements (SMPG)’ taken before meals, combined with carbohydrate counts, and planned physical activity, and calculates the required insulin dose. It transmits these ‘real-time data’ to medical staff via secured websites. 

This multi-center trial included 180 patients with poorly controlled T1DM (HbA1c levels of > 8%). All participants were asked to carry out two SMPG daily. They were then assigned to 1 of 3 groups.

Group 1 (60 patients) recorded blood sugar levels in a conventional paper log book and managed the required insulin dose without any telemedicine support. Follow up consultations were scheduled at 3 and 6 months. This was the control group.

Group 2 (61 patients) received a smartphone with Diabeo software, without the telemedicine service. Follow up visits were scheduled at 3 and 6 months.

Group 3 (59 patients) received the full Diabeo service, including insulin dose calculation and short tele-consultations (5-10 minutes) with a diabetes expert, once in every two weeks. Only one visit was scheduled at 6 months. 

After 6 months the most significant improvement in HbA1c levels was achieved in Group 3 with an average 0.91% reduction compared to control group (Group 1). The use of Diabeo without tele-consultation (Group 2) resulted in an average 0.67% reduction in HbA1c levels.

The Diabeo software impacts positively on the management of poorly controlled T1DM by providing ongoing professional input regarding the required insulin dose. It works best in conjunction with regular short tele-consultations, and thus greatly reduces the number of required visits to a health care providers.

Diabeo software was developed by Voluntis (Paris, France), in collaboration with CERITD. It did not yet gain Food and Drug Administration (FDA) 510(k) clearance (formal approval) for device marketing.