Diabetes Mellitus Type II,
Conditions
Keywords
Diabetes mellitus tip II, eHealth solution, Health Information Technology, quality of life, family medicine, satisfaction with e-health care, primary care
Brief summary
The purpose of the study is to clinically evaluate a new approach to treatment of patients with diabetes mellitus type II by using specially developed mobile-internet software solution. The effect of information and communication technologies (ICT) to improve the integrated care of people with diabetes will be identified, developed, introduced and clinically evaluated. The investigators expect that usage of an e-Health application in health care of patients with diabetes mellitus type II could improve the following healthcare outcomes: results of the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life.
Detailed description
Diabetes mellitus (DM) is defined as a group of common metabolic disorders that share the phenotype of hyperglycemia. It is generally agreed that in Caucasian populations the prevalence rate is between 2% and 6%. Prevalence rate of DM in SLovenia is about 5%. Type 2 DM accounts for 90% to 95% of all diabetes cases. Results of many clinical studies demonstrated the great potential of information and communication technology (ICT) applications to improve health care of patients with chronic diseases including diabetes mellitus. In this study an ICT mobile environment to improve the process of an integrated care of people with Diabetes mellitus will be identified, developed, introduced and clinically evaluated. The study will include 140 patients diagnosed with diabetes mellitus type II who are managed in primary care. The study will use and evaluation questionnaire that will cover issues regarding the patient quality of life. Subjects with a blood pressure meter and a scale, will be able to enter the value of the systolic and diastolic blood pressure and the body weight. Subjects will be motivated to regularly enter data about their blood pressure, body weight, dietary misconducts and to complete available questioners. In addition to this, users can enter values about their physical activity (type, duration, intensity).
Interventions
PROCEDUREComputerised support to the Diabetes type II patients
The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.
Sponsors
University of Ljubljana School of Medicine, Slovenia
University of Primorska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes, treated with non-pharmacological interventions or/and tablets (Non-Insulin-Dependent Diabetes Mellitus) * Internet connection and personal computer /lap-top computer * Mobile phone * Sufficient level of Internet and e-mail usage - checked by short questionnaire * Age \>18 or \<75 years
Exclusion criteria
* significant co-morbidity * Type 1 diabetes * Insulin-dependent type 2 diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in HbA1C at 1 Year. | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Functional Health Status Via WONCA-COOP Questionnaire. | one year | WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 ('no limitation at all') to 5 ('severely limited'); for 'change in health' score 1 means 'much better' and score 5'much worse'. Sub-scales are averaged to compute a total score. |
| Change of Blood Lipid Level ( Low Density Cholesterol) | baseline and one year | — |
| Body Mass Index at 1 Year | one year | — |
| Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. | baseline and one year | — |
| Change of the Following Parameter : HbA1C | baseline and six months | — |
| Quality of Patients' Life Via WONCA-COOP Questionnaire. | baseline and one year | — |
Countries
Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diabetes With ICT Support (E-diabetes) The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients
Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process. | 58 |
| Diabetes Without Support The group of randomly selected patients with DM type II, without software application and web-based support. | 62 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 8 |
Baseline characteristics
| Characteristic | Diabetes With ICT Support (E-diabetes) | Diabetes Without Support | Total |
|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 10.5 | 54.7 years STANDARD_DEVIATION 11.1 | 55.5 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 36 Participants | 37 Participants | 73 Participants |
| Years of DM treatment | 5.1 years STANDARD_DEVIATION 5.7 | 5.7 years STANDARD_DEVIATION 4.8 | 5.5 years STANDARD_DEVIATION 5.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 62 |
| serious Total, serious adverse events | 0 / 58 | 0 / 62 |
Outcome results
Primary
Change From Baseline in HbA1C at 1 Year.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes With ICT Support (E-diabetes) | Change From Baseline in HbA1C at 1 Year. | 0.6925 percentage of glycated haemoglobin | Standard Deviation 1.4708 |
| Diabetes Without Support | Change From Baseline in HbA1C at 1 Year. | 0.1707 percentage of glycated haemoglobin | Standard Deviation 1.0617 |
Comparison: Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.~The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05p-value: 0.00595% CI: [0.2221, 1.1629]t-test, 2 sided
Secondary
Body Mass Index at 1 Year
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes With ICT Support (E-diabetes) | Body Mass Index at 1 Year | 31.76 Kg/m2 | Standard Deviation 4.87 |
| Diabetes Without Support | Body Mass Index at 1 Year | 32.6 Kg/m2 | Standard Deviation 5.14 |
Secondary
Change of Blood Lipid Level ( Low Density Cholesterol)
Time frame: baseline and one year
Secondary
Change of Blood Lipid Level ( Low Density Cholesterol)
Time frame: baseline and six months
Secondary
Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Time frame: baseline and one year
Secondary
Change of the Following Parameter : HbA1C
Time frame: baseline and six months
Secondary
Patients' Functional Health Status Via WONCA-COOP Questionnaire.
WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 ('no limitation at all') to 5 ('severely limited'); for 'change in health' score 1 means 'much better' and score 5'much worse'. Sub-scales are averaged to compute a total score.
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes With ICT Support (E-diabetes) | Patients' Functional Health Status Via WONCA-COOP Questionnaire. | 2.12 units on a scale | Standard Deviation 0.66 |
| Diabetes Without Support | Patients' Functional Health Status Via WONCA-COOP Questionnaire. | 1.89 units on a scale | Standard Deviation 0.58 |
Secondary
Quality of Patients' Life Via WONCA-COOP Questionnaire.
Time frame: baseline and one year