An interventional study of Self-monitoring for patients with Diabetes mellitus type 2 and Nurse-monitoring for patients with Diabetes mellitus type 2 in Diabetes Mellitus Type 2, sponsored by Landeskrankenanstalten-Betriebsgesellschaft. Completed at 3 sites in Austria. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Landeskrankenanstalten-Betriebsgesellschaft · Not applicable, Interventional, and Supportive care
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 193 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Landeskrankenanstalten-Betriebsgesellschaft is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
treatment as usual
Patients are self-monitoring and submitting their vital parameters.
Other: Self-monitoring for patients with Diabetes mellitus type 2
Nurses are measuring and entering the vital parameters of the patients.
Other: Nurse-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 submitting the vital parameters of the patient via mobile device.
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
HbA1c
HbA1c was taken at the beginning of the study and after 12 months.
Time frame: 12 months
Blood Pressure
Time frame: 12 months
Blood Lipids
Time frame: 12 months
Body Weight
Time frame: 12 months
Medication Changes
Insulin, Change? -\> Yes/No
Time frame: 12 months
Presence of Diabetic Complications
Time frame: 12 months
Number of Hospitalisations
The number of inpatient stays comparing intervention and control group was conducted.
Time frame: 12 months
| Milestone | Control Group | Self-monitoring for Patients With Diabetes Mellitus Type 2 | Nurse-monitoring for Patients With Diabetes Mellitus Type 2 |
|---|---|---|---|
| Started | 76 | 114 | 3 |
| Completed | 61 | 101 | 0 |
| Not completed | 15 | 13 | 3 |
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.
| units on a scale (General health score) | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 |
|---|---|---|
| Physical Functioning 0-100 Score baseline | 69.2 ± 25.8 | 72.5 ± 25.2 |
| Physical Functioning 0-100 Score | 74.9 ± 24.1 | 77.1 ± 22.3 |
| Role Physical 0-100 Score baseline | 58.5 ± 29.5 | 63.8 ± 24.3 |
| Role Physical 0-100 Score | 68.3 ± 29.3 | 72.5 ± 25.1 |
| Bodily Pain 0-100 Score baseline | 59.8 ± 33.6 | 62.2 ± 31.0 |
| Bodily Pain 0-100 Score | 66.7 ± 30.9 | 66.5 ± 30.0 |
| General Health 0-100 Score baseline | 62.6 ± 19.3 | 62.2 ± 16.6 |
| General Health 0-100 Score | 67.9 ± 17.9 | 69.4 ± 18.8 |
| Vitality 0-100 Score baseline | 56.3 ± 25.7 | 58.4 ± 62.5 |
| Vitality 0-100 Score | 61.6 ± 23.6 | 63.2 ± 19.1 |
| Social Functioning 0-100 Score baseline | 80.1 ± 23.1 | 81.3 ± 22.1 |
| Social Functioning 0-100 Score | 86.7 ± 18.8 | 81.3 ± 26.6 |
| Role Emotional 0-100 Score baseline | 67.5 ± 28.2 | 70.7 ± 24.5 |
| Role Emotional 0-100 Score | 77.7 ± 28.4 | 78.7 ± 25.3 |
| Mental Health 0-100 Score baseline | 72.2 ± 21.7 | 72.1 ± 18.8 |
| Mental Health 0-100 Score | 76.1 ± 19.6 | 72.6 ± 20.1 |
| PCS Physical Component Score baseline | 43.7 ± 10.4 | 45.1 ± 9.9 |
| PCS Physical Component Score | 46.3 ± 9.6 | 47.9 ± 9.5 |
| MCS Mental Component Score baseline | 47.2 ± 11.9 | 47.9 ± 11.7 |
| MCS Mental Component Score | 50.6 ± 11.9 | 49.1 ± 11.6 |
HbA1c was taken at the beginning of the study and after 12 months.
| HbA1c [%] | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 |
|---|---|---|
| HbA1c values: first examination | 8.1 ± 1.2 | 8.7 ± 1.9 |
| HbA1c values after 12 months | 7.5 ± 1.1 | 7.5 ± 1.5 |
| mmHg | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 |
|---|---|---|
| diastolic baseline | 86.7 ± 12.9 | 88.9 ± 12.6 |
| systolic baseline | 150.4 ± 21.3 | 153.7 ± 23.1 |
| diastolic after 12 months | 85.2 ± 13.0 | 84.8 ± 12.6 |
| systolic after 12 months | 149.3 ± 21.1 | 148.7 ± 23.6 |
| mg/dL | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 |
|---|---|---|
| LDL Cholesterol after 12 months | 104.3 ± 38.7 | 107.6 ± 44.2 |
| LDL Cholesterol baseline | 107.5 ± 36.3 | 112.1 ± 42.5 |
| Cholesterol after 12 months | 185.2 ± 41.6 | 186.1 ± 51.3 |
| Cholesterol after baseline | 186.8 ± 37.8 | 197.6 ± 53.1 |
| HDL-cholesterol after 12 months | 51.3 ± 17.6 | 48.1 ± 16.9 |
| HDL-cholesterol baseline | 48.2 ± 16.8 | 47.1 ± 12.6 |
| kilograms | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 |
|---|---|---|
| body weight baseline | 90.2 ± 19.0 | 90.74 ± 20.0 |
| body weight after 12 months | 91.22 ± 19.32 | 91.64 ± 19.94 |
Insulin, Change? -\> Yes/No
No measurements were reported for this outcome.
No measurements were reported for this outcome.
The number of inpatient stays comparing intervention and control group was conducted.
| number of inpatient stays | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 |
|---|---|---|
| Number of Hospitalisations | 0.33 ± 0.63 | 0.38 ± 0.71 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/61 (0%) | 0/61 (0%) |
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | — | 0/101 (0%) | 0/101 (0%) |
| Age, Continuous(years) | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Total |
|---|---|---|---|
| Mean | 63.38 ± 11.13 | 60.35 ± 11.68 | 61.54 ± 11.46 |
| Sex: Female, Male(Participants) | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Total |
|---|---|---|---|
| Female | 31 | 55 | 86 |
| Male | 45 | 62 | 107 |
| Region of Enrollment(participants) | Control Group | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Total |
|---|---|---|---|
| Austria | 76 | 117 | 193 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Landeskrankenanstalten-Betriebsgesellschaft