Trial Outcomes & Findings for Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy (NCT NCT02423993)
NCT ID: NCT02423993
Last Updated: 2016-01-11
Results Overview
HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
4 month after CSII initiation
Results posted on
2016-01-11
Participant Flow
Participant milestones
| Measure |
SAP + Group Education
All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standart Education
Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
|
CSII + Group Education
Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standart Education
Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
23
|
19
|
|
Overall Study
COMPLETED
|
19
|
16
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy
Baseline characteristics by cohort
| Measure |
SAP + Group Education
n=19 Participants
All patients will be transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standart Education
n=16 Participants
Patients will be transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM will be used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received
|
CSII + Group Education
n=23 Participants
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standart Education
n=19 Participants
Patients will be transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by HbA1c. The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
29.5 years
n=5 Participants
|
33 years
n=7 Participants
|
27 years
n=5 Participants
|
23 years
n=4 Participants
|
26.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
23 participants
n=5 Participants
|
19 participants
n=4 Participants
|
77 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 month after CSII initiationPopulation: The analysis was "per protocol". Patients from group education groups were on MDI regymen and from standart education group were on insulin pump therapy during previously 4 months
HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.
Outcome measures
| Measure |
SAP + Group Education
n=19 Participants
All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standard Education
n=16 Participants
Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
|
CSII + Group Education
n=23 Participants
Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standard Education
n=19 Participants
Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
|
|---|---|---|---|---|
|
HbA1c
|
7.3 percentage
Interval 6.3 to 7.8
|
8.0 percentage
Interval 6.3 to 8.5
|
7.5 percentage
Interval 6.9 to 8.2
|
8.8 percentage
Interval 8.0 to 9.7
|
SECONDARY outcome
Timeframe: within 4 month of the studySevere hypoglycemia is defined аs an episode requiring assistance and will be confirmed by documentation of a blood glucose value of less than 50 mg per deciliter (2.8 mmol per liter) or recovery with restoration of plasma glucose.
Outcome measures
| Measure |
SAP + Group Education
n=19 Participants
All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standard Education
n=16 Participants
Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
|
CSII + Group Education
n=23 Participants
Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standard Education
n=19 Participants
Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
|
|---|---|---|---|---|
|
Severe Hypoglycaemia Frequency
|
0 events per month
Standard Deviation 0
|
0 events per month
Standard Deviation 0
|
0 events per month
Standard Deviation 0
|
0 events per month
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 4 month after CSII initiationPopulation: Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.
Will be assessed QoL changes during the study and differences of these changes between groups. ADDQoL Questionnaire includes 2 general scales and 18 specific scales. 2 general scales represent the general QoL and diabetes - dependent QoL (scales varies from -3 (worse) to +3 (better)). 18 specific scales represent the impact of diabetes on certain QoL parameters: working life, family life, social life, sex life, physical appearance, do physically, leisure, travel, confidence in ability, motivation, society reaction, future, finances, dependence, living conditions, freedom to eat, other's , freedom to drink. All scales varies from -9 (worse) to +9 (better).
Outcome measures
| Measure |
SAP + Group Education
n=19 Participants
All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standard Education
n=16 Participants
Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
|
CSII + Group Education
n=23 Participants
Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standard Education
n=19 Participants
Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
|
|---|---|---|---|---|
|
Quality of Life (ADDQoL Questionnaire)
Working life (ADDQoL)
|
-1.68 units on a scale
Standard Deviation 1.7
|
-1.08 units on a scale
Standard Deviation 2.19
|
-1.09 units on a scale
Standard Deviation 1.44
|
-2.59 units on a scale
Standard Deviation 2.39
|
|
Quality of Life (ADDQoL Questionnaire)
Family life (ADDQoL)
|
-0.74 units on a scale
Standard Deviation 3.07
|
-1.08 units on a scale
Standard Deviation 2.19
|
-1.09 units on a scale
Standard Deviation 1.44
|
-2.59 units on a scale
Standard Deviation 2.39
|
|
Quality of Life (ADDQoL Questionnaire)
Social life (ADDQoL)
|
-0.37 units on a scale
Standard Deviation 0.76
|
-1.67 units on a scale
Standard Deviation 2.35
|
-0.09 units on a scale
Standard Deviation 0.42
|
-1.53 units on a scale
Standard Deviation 2.8
|
|
Quality of Life (ADDQoL Questionnaire)
Sex life (ADDQoL)
|
-0.89 units on a scale
Standard Deviation 1.29
|
-1.33 units on a scale
Standard Deviation 1.92
|
-0.27 units on a scale
Standard Deviation 0.7
|
-1.94 units on a scale
Standard Deviation 2.11
|
|
Quality of Life (ADDQoL Questionnaire)
Physical appearance (ADDQoL)
|
-1.0 units on a scale
Standard Deviation 1.37
|
-0.83 units on a scale
Standard Deviation 1.27
|
-0.61 units on a scale
Standard Deviation 1.23
|
-1.47 units on a scale
Standard Deviation 2.06
|
|
Quality of Life (ADDQoL Questionnaire)
Do physically (ADDQoL)
|
-2.47 units on a scale
Standard Deviation 2.04
|
-2.50 units on a scale
Standard Deviation 2.28
|
-1.35 units on a scale
Standard Deviation 1.03
|
-3.53 units on a scale
Standard Deviation 2.93
|
|
Quality of Life (ADDQoL Questionnaire)
Holidays/leisure (ADDQoL)
|
-1.32 units on a scale
Standard Deviation 1.89
|
-1.75 units on a scale
Standard Deviation 2.86
|
-0.7 units on a scale
Standard Deviation 1.55
|
-2.11 units on a scale
Standard Deviation 2.69
|
|
Quality of Life (ADDQoL Questionnaire)
Travel (ADDQoL)
|
-1.32 units on a scale
Standard Deviation 1.53
|
-1.67 units on a scale
Standard Deviation 3.03
|
-0.96 units on a scale
Standard Deviation 1.58
|
-2.32 units on a scale
Standard Deviation 2.91
|
|
Quality of Life (ADDQoL Questionnaire)
Confidence in ability (ADDQoL)
|
-1.32 units on a scale
Standard Deviation 1.45
|
1.50 units on a scale
Standard Deviation 1.73
|
-0.65 units on a scale
Standard Deviation 0.88
|
-2.16 units on a scale
Standard Deviation 2.34
|
|
Quality of Life (ADDQoL Questionnaire)
Motivation (ADDQoL)
|
-0.53 units on a scale
Standard Deviation 1.22
|
-0.33 units on a scale
Standard Deviation 3.47
|
-0.13 units on a scale
Standard Deviation 1.01
|
-0.63 units on a scale
Standard Deviation 3.42
|
|
Quality of Life (ADDQoL Questionnaire)
Society reaction (ADDQoL)
|
0 units on a scale
Standard Deviation 0
|
-0.50 units on a scale
Standard Deviation 1.24
|
-0.04 units on a scale
Standard Deviation 0.47
|
-0.79 units on a scale
Standard Deviation 1.65
|
|
Quality of Life (ADDQoL Questionnaire)
Future (ADDQoL)
|
-2.21 units on a scale
Standard Deviation 2.3
|
-4.42 units on a scale
Standard Deviation 3.34
|
-1.74 units on a scale
Standard Deviation 2.26
|
-4.11 units on a scale
Standard Deviation 2.85
|
|
Quality of Life (ADDQoL Questionnaire)
Finances (ADDQoL)
|
-1.05 units on a scale
Standard Deviation 2.55
|
-1.75 units on a scale
Standard Deviation 1.71
|
-1.30 units on a scale
Standard Deviation 1.79
|
-2.89 units on a scale
Standard Deviation 2.92
|
|
Quality of Life (ADDQoL Questionnaire)
Dependence (ADDQoL)
|
-0.42 units on a scale
Standard Deviation 0.84
|
-1.83 units on a scale
Standard Deviation 2.48
|
-0.36 units on a scale
Standard Deviation 1.05
|
-1.21 units on a scale
Standard Deviation 2.07
|
|
Quality of Life (ADDQoL Questionnaire)
Living conditions (ADDQoL)
|
-0.11 units on a scale
Standard Deviation 1.2
|
-0.25 units on a scale
Standard Deviation 1.22
|
-0.18 units on a scale
Standard Deviation 0.59
|
-0.74 units on a scale
Standard Deviation 1.56
|
|
Quality of Life (ADDQoL Questionnaire)
Freedom to eat (ADDQoL)
|
-0.95 units on a scale
Standard Deviation 1.31
|
-3.50 units on a scale
Standard Deviation 3.53
|
-1.86 units on a scale
Standard Deviation 1.90
|
-2.95 units on a scale
Standard Deviation 2.34
|
|
Quality of Life (ADDQoL Questionnaire)
Other's fuss (ADDQoL)
|
-0.47 units on a scale
Standard Deviation 1.02
|
-1.17 units on a scale
Standard Deviation 1.99
|
-0.50 units on a scale
Standard Deviation 1.10
|
-0.95 units on a scale
Standard Deviation 2.55
|
|
Quality of Life (ADDQoL Questionnaire)
Freedom to drink (ADDQoL)
|
-1.11 units on a scale
Standard Deviation 1.63
|
-1.58 units on a scale
Standard Deviation 2.12
|
-1.09 units on a scale
Standard Deviation 1.38
|
-1.89 units on a scale
Standard Deviation 2.18
|
|
Quality of Life (ADDQoL Questionnaire)
Present QoL (ADDQoL)
|
1.00 units on a scale
Standard Deviation 1.05
|
0.83 units on a scale
Standard Deviation 1.34
|
1.09 units on a scale
Standard Deviation 0.79
|
1.0 units on a scale
Standard Deviation 1.0
|
|
Quality of Life (ADDQoL Questionnaire)
Diabetes-related QoL (ADDQoL)
|
-1.32 units on a scale
Standard Deviation 1.0
|
-1.58 units on a scale
Standard Deviation 1.0
|
-1.13 units on a scale
Standard Deviation 1.06
|
-1.74 units on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: within 4 month of the studyNonsevere hypoglycemia is defined аs an episode of a blood glucose value of less than 70 mg per deciliter (3.9 mmol per liter). All hypoglycaemia episodes was reported in patients dairies and then will be assessed and compared between groups.
Outcome measures
| Measure |
SAP + Group Education
n=19 Participants
All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standard Education
n=16 Participants
Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
|
CSII + Group Education
n=23 Participants
Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standard Education
n=19 Participants
Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
|
|---|---|---|---|---|
|
Nonsevere Hypoglycaemia Frequency
|
0.13 events per day
Standard Deviation 0.43
|
0.49 events per day
Standard Deviation 0.91
|
0.43 events per day
Standard Deviation 0.72
|
0.004 events per day
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: within 4 month of the studySeveral glucose variability scores was assessed: SD, MAGE, MODD, LI, HBGI, LBGI, MAG. For SAP users glucose variability scores were calculated from CGM data. For CSII users with SMBG only glucose variability scores were calculated from "bolus calculator" (Bolus Wizard) data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 4 month of the studyTreatment compliance evaluation was based on frequency of SMBG and bolus calculator use as one of the factors mediating achievement of target plasma glucose level.
Outcome measures
| Measure |
SAP + Group Education
n=19 Participants
All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standard Education
n=16 Participants
Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
|
CSII + Group Education
n=23 Participants
Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standard Education
n=19 Participants
Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
|
|---|---|---|---|---|
|
Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)
frequency of SMBG
|
6.7 events
Standard Deviation 3.6
|
7.1 events
Standard Deviation 6.2
|
4.6 events
Standard Deviation 2.1
|
3.6 events
Standard Deviation 2.4
|
|
Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)
frequency of bolus calculator use
|
6.0 events
Standard Deviation 2.7
|
5.4 events
Standard Deviation 3.2
|
6.9 events
Standard Deviation 3.2
|
4.8 events
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 4 months after CSII initiationPopulation: Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.
We assessed QoL changes during the study and differences of these changes between groups. SF-36 questionnaire enabling evaluation of patient's satisfaction with his health status and certain emotional characteristics. 36 items of the Questionnaire are grouped in 8 scales. Each scale ranges from 0 to 100, the latter representing full health.
Outcome measures
| Measure |
SAP + Group Education
n=19 Participants
All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
SAP + Standard Education
n=16 Participants
Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
|
CSII + Group Education
n=23 Participants
Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII.
|
CSII + Standard Education
n=19 Participants
Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
|
|---|---|---|---|---|
|
Quality of Life (SF36 Questionnaire)
Physical Functioning
|
95 units on a scale
Interval 85.0 to 100.0
|
85 units on a scale
Interval 70.0 to 95.0
|
95 units on a scale
Interval 90.0 to 100.0
|
95 units on a scale
Interval 85.0 to 100.0
|
|
Quality of Life (SF36 Questionnaire)
Role-Physical Functioning
|
88 units on a scale
Interval 63.0 to 100.0
|
100 units on a scale
Interval 38.0 to 100.0
|
100 units on a scale
Interval 75.0 to 100.0
|
75 units on a scale
Interval 75.0 to 100.0
|
|
Quality of Life (SF36 Questionnaire)
Bodily Pain
|
100 units on a scale
Interval 84.0 to 100.0
|
63 units on a scale
Interval 42.0 to 92.0
|
100 units on a scale
Interval 84.0 to 100.0
|
84 units on a scale
Interval 62.0 to 100.0
|
|
Quality of Life (SF36 Questionnaire)
General Health
|
67 units on a scale
Interval 60.0 to 72.0
|
67 units on a scale
Interval 15.0 to 87.0
|
67 units on a scale
Interval 57.0 to 82.0
|
61 units on a scale
Interval 37.0 to 67.0
|
|
Quality of Life (SF36 Questionnaire)
Vitality
|
70 units on a scale
Interval 55.0 to 80.0
|
72.5 units on a scale
Interval 33.0 to 80.0
|
65 units on a scale
Interval 60.0 to 75.0
|
60 units on a scale
Interval 40.0 to 75.0
|
|
Quality of Life (SF36 Questionnaire)
Social Functioning
|
88 units on a scale
Interval 75.0 to 100.0
|
68.8 units on a scale
Interval 50.0 to 88.0
|
88 units on a scale
Interval 63.0 to 100.0
|
75 units on a scale
Interval 63.0 to 88.0
|
|
Quality of Life (SF36 Questionnaire)
Role Emotional
|
100 units on a scale
Interval 67.0 to 100.0
|
83 units on a scale
Interval 67.0 to 100.0
|
100 units on a scale
Interval 67.0 to 100.0
|
67 units on a scale
Interval 33.0 to 100.0
|
|
Quality of Life (SF36 Questionnaire)
Mental Health
|
72 units on a scale
Interval 62.0 to 80.0
|
72 units on a scale
Interval 54.0 to 76.0
|
68 units on a scale
Interval 60.0 to 84.0
|
60 units on a scale
Interval 40.0 to 76.0
|
Adverse Events
SAP + Group Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAP + Standard Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSII + Group Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSII + Standard Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lyudmila Ibragimova
Endocrinology Research Centre, Moscow
Phone: +7 9266180811
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place