Impact of telemonitoring on insulin-treated diabetes mellitus

Impact and duration effect of telemonitoring on HbA1c, BMI and cost in patients with inefficiently controlled insulin-treated diabetes mellitus

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000977673

Enrollment

115

Registered

2014-09-11

Start date

2012-10-01

Completion date

2013-07-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Primary goal was to monitor and control the blood glucose levels in inefficiently insulin-treated patients with diabetes (DM) using a telemonitoring system and determine whether the improvement of HbA1c had a lasting effect following its discontinuation.

Interventions

TELEMONITORING A 8x5x3 cm modem was provided to insufficiently insulin-treated diabetes mellitus patients, which could be connected to their glucose-meters through a USB cable. Blood glucose measurements were transmitted from the glucose-meters to the computers of the Department of Endocrinology via this modem. At least 4 blood glucose measurements per day were suggested. Data were transmitted at least once per day. Storage, documentation and communication with patients were achieved through specialized integrated software (Telemedicor, Hertfordshire-UK). An endocrinologist rviewed data and contacted participants with mobile-phone SMS or e-mails when necessary. Frequency of doctor to patient communication, varied among patients depending on glucose values and compliance. Intervention period was 6 months Alerts were also set for high ( greater than 300 mg/dL) or low (lower than 70 mg/dL) glucose levels. When a high or low glucose alert was activated, the endocrinologist received a text message on his mobile phone thus allowing prompt communication with the patient and proper therapeutic adjustments when necessary.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

Individuals aged 15 years and older, with type 1 and type 2 DM, receiving any kind of insulin treatment (intensified, basal-bolus, mixtures) +/- oral glucose lowering agents and insufficient control of insulin-treated DM with a HbA1c equal or greater than 7.5% and at the same time lower than 10% despite at least two years of follow up at the outpatient department. Patients should be able to hear and see well enough to use the equipment. Additional inclusion criteria were recent hospitalization for newly diagnosed DM in conjunction with HbA1c equal or greater than 10%, as well as distance from specialized medical facilities.

Exclusion criteria

Acute uncontrolled mental illness and inability to see well.

Outcome results