Diabetes Mellitus Type 2
Conditions
Brief summary
Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.
Interventions
OTHERSelf-monitoring for patients with Diabetes mellitus type 2
Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
OTHERNurse-monitoring for patients with Diabetes mellitus type 2
Nurses are submitting the vital parameters of the patient via mobile device.
Sponsors
European Commission
Landeskrankenanstalten-Betriebsgesellschaft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* T2DM diagnosed \> 3 months prior to the enrollment * HbA1c \>= 6,5 % * Capability of filling questionnaires by their own language * Being able to use the devices provided * Being cognitively able to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | 12 months | The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests. |
| HbA1c | 12 months | HbA1c was taken at the beginning of the study and after 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 12 months | — |
| Blood Lipids | 12 months | — |
| Body Weight | 12 months | — |
| Medication Changes | 12 months | Insulin, Change? -\> Yes/No |
| Presence of Diabetic Complications | 12 months | — |
| Number of Hospitalisations | 12 months | The number of inpatient stays comparing intervention and control group was conducted. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group treatment as usual | 76 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module. | 117 |
| Total | 193 |
Baseline characteristics
| Characteristic | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Total |
|---|---|---|---|
| Age, Continuous | 63.38 years STANDARD_DEVIATION 11.13 | 60.35 years STANDARD_DEVIATION 11.68 | 61.54 years STANDARD_DEVIATION 11.46 |
| Region of Enrollment Austria | 76 participants | 117 participants | 193 participants |
| Sex: Female, Male Female | 31 Participants | 55 Participants | 86 Participants |
| Sex: Female, Male Male | 45 Participants | 62 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 101 |
| serious Total, serious adverse events | 0 / 61 | 0 / 101 |
Outcome results
Primary
HbA1c
HbA1c was taken at the beginning of the study and after 12 months.
Time frame: 12 months
Population: No patients of the Nurse-Monitoring Group finished the study, as a consequence no HbA1c after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | HbA1c | HbA1c values: first examination | 8.1 HbA1c [%] | Standard Deviation 1.2 |
| Control Group | HbA1c | HbA1c values after 12 months | 7.5 HbA1c [%] | Standard Deviation 1.1 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | HbA1c | HbA1c values: first examination | 8.7 HbA1c [%] | Standard Deviation 1.9 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | HbA1c | HbA1c values after 12 months | 7.5 HbA1c [%] | Standard Deviation 1.5 |
p-value: 0.025Wilcoxon (Mann-Whitney)
Primary
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests.
Time frame: 12 months
Population: No patients of the Nurse-Monitoring Group finished the study, as a consequence no SF36 after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Physical Functioning 0-100 Score baseline | 69.2 units on a scale (General health score) | Standard Deviation 25.8 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Physical Functioning 0-100 Score | 74.9 units on a scale (General health score) | Standard Deviation 24.1 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Physical 0-100 Score baseline | 58.5 units on a scale (General health score) | Standard Deviation 29.5 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Physical 0-100 Score | 68.3 units on a scale (General health score) | Standard Deviation 29.3 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Bodily Pain 0-100 Score baseline | 59.8 units on a scale (General health score) | Standard Deviation 33.6 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Bodily Pain 0-100 Score | 66.7 units on a scale (General health score) | Standard Deviation 30.9 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | General Health 0-100 Score baseline | 62.6 units on a scale (General health score) | Standard Deviation 19.3 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | General Health 0-100 Score | 67.9 units on a scale (General health score) | Standard Deviation 17.9 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Vitality 0-100 Score baseline | 56.3 units on a scale (General health score) | Standard Deviation 25.7 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Vitality 0-100 Score | 61.6 units on a scale (General health score) | Standard Deviation 23.6 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Social Functioning 0-100 Score baseline | 80.1 units on a scale (General health score) | Standard Deviation 23.1 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Social Functioning 0-100 Score | 86.7 units on a scale (General health score) | Standard Deviation 18.8 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Emotional 0-100 Score baseline | 67.5 units on a scale (General health score) | Standard Deviation 28.2 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Emotional 0-100 Score | 77.7 units on a scale (General health score) | Standard Deviation 28.4 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Mental Health 0-100 Score baseline | 72.2 units on a scale (General health score) | Standard Deviation 21.7 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Mental Health 0-100 Score | 76.1 units on a scale (General health score) | Standard Deviation 19.6 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | PCS Physical Component Score baseline | 43.7 units on a scale (General health score) | Standard Deviation 10.4 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | PCS Physical Component Score | 46.3 units on a scale (General health score) | Standard Deviation 9.6 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | MCS Mental Component Score baseline | 47.2 units on a scale (General health score) | Standard Deviation 11.9 |
| Control Group | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | MCS Mental Component Score | 50.6 units on a scale (General health score) | Standard Deviation 11.9 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | PCS Physical Component Score | 47.9 units on a scale (General health score) | Standard Deviation 9.5 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Physical Functioning 0-100 Score baseline | 72.5 units on a scale (General health score) | Standard Deviation 25.2 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Social Functioning 0-100 Score baseline | 81.3 units on a scale (General health score) | Standard Deviation 22.1 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Physical Functioning 0-100 Score | 77.1 units on a scale (General health score) | Standard Deviation 22.3 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Mental Health 0-100 Score | 72.6 units on a scale (General health score) | Standard Deviation 20.1 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Physical 0-100 Score baseline | 63.8 units on a scale (General health score) | Standard Deviation 24.3 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Social Functioning 0-100 Score | 81.3 units on a scale (General health score) | Standard Deviation 26.6 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Physical 0-100 Score | 72.5 units on a scale (General health score) | Standard Deviation 25.1 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | MCS Mental Component Score | 49.1 units on a scale (General health score) | Standard Deviation 11.6 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Bodily Pain 0-100 Score baseline | 62.2 units on a scale (General health score) | Standard Deviation 31 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Emotional 0-100 Score baseline | 70.7 units on a scale (General health score) | Standard Deviation 24.5 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Bodily Pain 0-100 Score | 66.5 units on a scale (General health score) | Standard Deviation 30 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | PCS Physical Component Score baseline | 45.1 units on a scale (General health score) | Standard Deviation 9.9 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | General Health 0-100 Score baseline | 62.2 units on a scale (General health score) | Standard Deviation 16.6 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Role Emotional 0-100 Score | 78.7 units on a scale (General health score) | Standard Deviation 25.3 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | General Health 0-100 Score | 69.4 units on a scale (General health score) | Standard Deviation 18.8 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | MCS Mental Component Score baseline | 47.9 units on a scale (General health score) | Standard Deviation 11.7 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Vitality 0-100 Score baseline | 58.4 units on a scale (General health score) | Standard Deviation 62.5 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Mental Health 0-100 Score baseline | 72.1 units on a scale (General health score) | Standard Deviation 18.8 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire | Vitality 0-100 Score | 63.2 units on a scale (General health score) | Standard Deviation 19.1 |
Secondary
Blood Lipids
Time frame: 12 months
Population: Not all Participants delivered reliable data; Measurements at the beginning of the trial and after 12 months; No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood lipids after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Blood Lipids | Cholesterol after 12 months | 185.2 mg/dL | Standard Deviation 41.6 |
| Control Group | Blood Lipids | HDL-cholesterol baseline | 48.2 mg/dL | Standard Deviation 16.8 |
| Control Group | Blood Lipids | Cholesterol after baseline | 186.8 mg/dL | Standard Deviation 37.8 |
| Control Group | Blood Lipids | LDL Cholesterol baseline | 107.5 mg/dL | Standard Deviation 36.3 |
| Control Group | Blood Lipids | HDL-cholesterol after 12 months | 51.3 mg/dL | Standard Deviation 17.6 |
| Control Group | Blood Lipids | LDL Cholesterol after 12 months | 104.3 mg/dL | Standard Deviation 38.7 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Lipids | HDL-cholesterol after 12 months | 48.1 mg/dL | Standard Deviation 16.9 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Lipids | LDL Cholesterol after 12 months | 107.6 mg/dL | Standard Deviation 44.2 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Lipids | LDL Cholesterol baseline | 112.1 mg/dL | Standard Deviation 42.5 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Lipids | Cholesterol after 12 months | 186.1 mg/dL | Standard Deviation 51.3 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Lipids | Cholesterol after baseline | 197.6 mg/dL | Standard Deviation 53.1 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Lipids | HDL-cholesterol baseline | 47.1 mg/dL | Standard Deviation 12.6 |
Secondary
Blood Pressure
Time frame: 12 months
Population: Not all Participants delivered data, reliable data was used. No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood pressure after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Blood Pressure | diastolic baseline | 86.7 mmHg | Standard Deviation 12.9 |
| Control Group | Blood Pressure | systolic baseline | 150.4 mmHg | Standard Deviation 21.3 |
| Control Group | Blood Pressure | diastolic after 12 months | 85.2 mmHg | Standard Deviation 13 |
| Control Group | Blood Pressure | systolic after 12 months | 149.3 mmHg | Standard Deviation 21.1 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Pressure | systolic after 12 months | 148.7 mmHg | Standard Deviation 23.6 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Pressure | diastolic baseline | 88.9 mmHg | Standard Deviation 12.6 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Pressure | diastolic after 12 months | 84.8 mmHg | Standard Deviation 12.6 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Blood Pressure | systolic baseline | 153.7 mmHg | Standard Deviation 23.1 |
Comparison: Blood pressure: diastolicp-value: 0.182Wilcoxon (Mann-Whitney)
Secondary
Body Weight
Time frame: 12 months
Population: baseline demographic characteristics; No patients of the Nurse-Monitoring Group finished the study, as a consequence no Body weight after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Body Weight | body weight baseline | 90.2 kilograms | Standard Deviation 19 |
| Control Group | Body Weight | body weight after 12 months | 91.22 kilograms | Standard Deviation 19.32 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Body Weight | body weight baseline | 90.74 kilograms | Standard Deviation 20 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Body Weight | body weight after 12 months | 91.64 kilograms | Standard Deviation 19.94 |
Secondary
Medication Changes
Insulin, Change? -\> Yes/No
Time frame: 12 months
Population: No data about medical changes could be analysed at the end of the study, no data were collected.
Secondary
Number of Hospitalisations
The number of inpatient stays comparing intervention and control group was conducted.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Hospitalisations | 0.33 number of inpatient stays | Standard Deviation 0.63 |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Number of Hospitalisations | 0.38 number of inpatient stays | Standard Deviation 0.71 |
Secondary
Presence of Diabetic Complications
Time frame: 12 months
Population: No data about the presence of diabetic complications could be analysed at the end of the study, no data was collected for this secondary outcome.