Impact of telemonitoring on insulin-treated diabetes mellitus

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000977673
• Date of registration: 11/09/2014
• Prospective Registration: No
• Primary sponsor: George Piaditis
• Public title: Impact of telemonitoring on insulin-treated diabetes mellitus
• Scientific title: Impact and duration effect of telemonitoring on HbA1c, BMI and cost in patients with inefficiently controlled insulin-treated diabetes mellitus
• Date of first enrolment: 01/10/2012
• Target sample size: 115
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000977673.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: Dr George Piaditis

• Name: Dr Stelios Fountoulakis

Key inclusion & exclusion criteria

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.

Age minimum: 15 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Diabetes mellitus;
Diabetes mellitus

Intervention(s)

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.

Primary Outcome(s)

Primary Outcome 1: Glycosylated Hemoglobin [HbA1c (%)]
HbA1c was measured by HPLC (MENARINI diagnostics HA-8160)
[Timepoint: at randomization, 3 and 6 months after randomization and 6 months following intervention's (blood glucose telemonitoring)discontinuation.]

Secondary Outcome(s)

Secondary Outcome 1: Body Mass Index (BMI)

Weight was measured by researcher using calibrated digital scale whereas height was measured by researcher using a stadiometer.[Timepoint: at randomization, 6 months after randomization and 6 months following intervention's (blood glucose telemonitoring)discontinuation.]

Secondary Outcome 2: Cost in Euros

Patients on telemonitoring completed a structured questionnaire regarding the total financial cost of a regular outpatient department visit and their net daily salary. Cost of conventional outpatient department follow-up was evaluated through the formula TCequals to T plus HF plus O (TC; total cost, T; transportation cost, HF; standard 5 euros hospital fee, O; other expenses) based on patients’ questionnaires answers. Transportation cost depended on the means of transportation used by each patient and any accompanying persons. Other expenses included money consumed on stay, food, beverages and additional expenses during travel to the hospital.[Timepoint: at 6 months after randomization. ]

Secondary Outcome 4: Number of blood glucose measurements per month

Data were uploaded from the participants' glucose-meters to computers at the Department of Endocrinology[Timepoint: at 6 months after randomization]

Secondary Outcome 3: Frequency of hyperglycemias and hypoglycemias

Data were obtained by patient's glucosemeter measurements[Timepoint: at 6 months after randomization ]

Secondary ID(s)

None

Ethics review

Status: Approved
Approval date:
Contact:

Scientific Commitee of the General Hospital of Athens "G.Gennimatas"