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Trial registered on ANZCTR


Trial ID
ACTRN12614000977673
Ethics application status
Approved
Date submitted
27/08/2014
Date registered
11/09/2014
Date last updated
11/09/2014
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285236 0
None
Universal Trial Number (UTN)
U1111-1160-8514
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 292868 0
Condition category
Condition code
Metabolic and Endocrine 293165 293165 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290110 0
Treatment: Devices
Comparator / control treatment
Usual bimonthly outpatient care and follow-up at the Department of Endocrinology.
Control group
Active

Outcomes
Primary outcome [1] 293019 0
Primary Outcome 1: Glycosylated Hemoglobin [HbA1c (%)]
HbA1c was measured by HPLC (MENARINI diagnostics HA-8160)
Timepoint [1] 293019 0
Timepoint: at randomization, 3 and 6 months after randomization and 6 months following intervention's (blood glucose telemonitoring)discontinuation.
Secondary outcome [1] 310163 0
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 [1] 310163 0
Timepoint: at randomization, 6 months after randomization and 6 months following intervention's (blood glucose telemonitoring)discontinuation.
Secondary outcome [2] 310164 0
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 [2] 310164 0
Timepoint: at 6 months after randomization.
Secondary outcome [3] 310165 0
Secondary Outcome 3: Frequency of hyperglycemias and hypoglycemias

Data were obtained by patient's glucosemeter measurements
Timepoint [3] 310165 0
Timepoint: at 6 months after randomization
Secondary outcome [4] 310168 0
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 [4] 310168 0
Timepoint: at 6 months after randomization

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute uncontrolled mental illness and inability to see well.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table created by computer software

Randomization was 2:1 (patients on telemonitoring vs patients on conventional out-patient care follow-up).



Subgroups
Recently diagnosed and hospitalized DM patients with HbA1c equal or greater of 10% who were started with any kind of insulin treatment were assigned to groups TG10 and CG10.

Groups TG 7.5 and CG7.5 included insulin-treated DM patients with insufficient control (HbA1c equal or greater of 7.5 and at the same time lower than 10%) despite at least two years of follow up at the outpatient department at bimonthly intervals.
TG and CG patients were also divided in Type 1 DM groups (TG1 and CG1) and Type 2 DM groups (TG2 and CG2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical analysis was performed using the SPSS software package (SPSS Inc., version 17.0, Chicago, USA).

Within-group difference scores were compared with one- way ANOVA and t-test in normally distributed values whereas one-way ANOVA plus Wilcoxon test was utilized in non-normally distributed ones.

Between-group comparisons of difference scores were obtained by using a t-test in the case of normally distributed values and Mann-Whitney in non-normally distributed ones.

Associations between variables were estimated in both groups with the use of Pearson correlation coefficients.

The number of participants needed to achieve study objectives were determined by previously published studies on telemonitoring (1,2) as well as a recent meta-analysis (3) regarding the effect of telemonitoring on HbA1c. Moreover, we used a power analysis based on published results, to estimate the necessary sample size.
In the vast majority of studies identified, sample sizes ranged from a total of 49 patients (26 in the telemonitoring group) to 182 patients (94 in the telemonitoring group) (1,4). In most of these studies, despite the relative small sample size, the results were statistically significant because of the large effect between the two interventions.
Regarding power analysis, based on data from the study of Bogner et al (1), we found that for a significance level of 0.05 our study should recruit 23 subjects per group to achieve a 90% power or 17 subjects per group in order to obtain a 80% power. Based on these results and on the sample sizes we found at the literature, we decided to increase our sample size to a total of 115 patients. From these, we allocated 76 patients in the intervention group (from those, six were lost to follow-up), to study the intervention effects with more precision.



1. Bogner HR et al, 2012, Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial. Ann Fam Med 10:15–22.
2. Stone RA et al, 2010, Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care 33:478-484.
3. Marcolino MS et al, 2013, Telemedicine Application in the Care of Diabetes Patients: Systematic Review and Meta-Analysis. Plos One, 8: e79246.
4. Whittemore R et al, 2004, A nurse-coaching intervention for women with type 2 diabetes. Diabetes Educ 30:795–804.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6311 0
Greece
State/province [1] 6311 0

Funding & Sponsors
Funding source category [1] 289851 0
Self funded/Unfunded
Name [1] 289851 0
Address [1] 289851 0
Country [1] 289851 0
Primary sponsor type
Individual
Name
George Piaditis
Address
General Hospital of Athens "G. Gennimatas"
Mesogeion Avenue 154, PC 11527
Holargos, Athens, Greece
Country
Greece
Secondary sponsor category [1] 288535 0
None
Name [1] 288535 0
Address [1] 288535 0
Country [1] 288535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291583 0
Scientific Commitee of the General Hospital of Athens "G.Gennimatas"
Ethics committee address [1] 291583 0
General Hospital of Athens "G. Gennimatas"
154 Mesogeion Avenue
PC 11527
Holargos, Athens, Greece
Ethics committee country [1] 291583 0
Greece
Date submitted for ethics approval [1] 291583 0
Approval date [1] 291583 0
22/05/2012
Ethics approval number [1] 291583 0
11783

Summary
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.
Trial website
Trial related presentations / publications
1) Monitoring and control of blood glucose levels in patients with inefficiently controlled insulin-treated diabetes mellitus through the utilization of an on-line telemonitoring system
Fountoulakis Stelios; Papanastasiou Labrini; Marakaki Chrisanthi; Anastasakou Marina; Piaditis George. Endocrine Abstracts (2013) 32 P470.

2) Improvement of HbA1c is blunted following discontinuation of an on-line telemonitoring system, in patients with inefficiently controlled insulin-treated diabetes mellitus. Fountoulakis Stelios; Papanastasiou Labrini; Malliopoulos Dimosthenis; Marakaki Chrisanthi; Markou Athina; Kounadi Theodora; Piaditis George
Endocrine Abstracts (2014) 35 P475.
Public notes
Study groups
Group 1 consisted of 70 patients with DM (16 with Type 1 and 56 with Type 2) who participated in the telemonitoring (telemonitoring group-TG).Group 2 included 35 DM patients (9 with Type 1 and 26 with Type 2) who continued outpatient care and follow-up, at bimonthly intervals, at the Department of Endocrinology (control group-CG).

Contacts
Principal investigator
Name 50982 0
Dr George Piaditis
Address 50982 0
General Hospital of Athens "G. Gennimatas"
154 Mesogeion avenue
PC 11527
Holargos, Athens, Greece
Country 50982 0
Greece
Phone 50982 0
+302107768283
Fax 50982 0
Email 50982 0
st_foun@yahoo.com
Contact person for public queries
Name 50983 0
Dr George Piaditis
Address 50983 0
General Hospital of Athens "G. Gennimatas"
154 Mesogeion avenue
PC 11527
Holargos, Athens, Greece
Country 50983 0
Greece
Phone 50983 0
+302107768283
Fax 50983 0
Email 50983 0
st_foun@yahoo.com
Contact person for scientific queries
Name 50984 0
Dr Stelios Fountoulakis
Address 50984 0
General Hospital of Athens "G. Gennimatas"
154 Mesogeion avenue
PC 11527
Holargos, Athens, Greece
Country 50984 0
Greece
Phone 50984 0
+302107768283
Fax 50984 0
Email 50984 0
st_foun@yahoo.com