ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    15386817 [PUBMED-IDS]

Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy (EASEDIAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02423993
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Ibragimova Lyudmila, Endocrinology Research Centre, Moscow

Brief Summary:
The purpose of this study is to assess the effectiveness of structured group education on glycemic control and Quality of Life (QoL) among users of continuous subcutaneous insulin infusions (CSII).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: Education by structured programme Device: CSII Device: CGM-RT Procedure: Screening for Complications Procedure: Glycaemic control assessment Procedure: QoL assessment Procedure: Knowledge assessment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency Assessment of the Structured Education Program for Type 1 Diabetes Patients on Insulin Pump Therapy
Study Start Date : October 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
Behavioral: Education by structured programme
Thе structured programme was developed in Endocrinology Research Centre. It is based on the following principles: education in group setting, using structured program; intensive insulin treatment using insulin pumps; self-adjustment of insulin dose and pump settings; intensive self-monitoring of blood glucose, including continuous glucose monitoring in real-time ("CGM-RT"); flexible physical activities and meals regimen (liberal diet, based on carbohydrates account using bread units; possible shifts of meals schedule and volume supported by appropriate treatment adjustment). Duration of education course - 8 days (35-37 hours); planned group volume is 7-10 patients.

Device: CSII
The intensified insulin therapy by means of continuous subcutaneous insulin infusion will be provide by Medtronic insulin pumps: Paradigm MMT-712/715, Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.

Device: CGM-RT
Continuous glucose monitoring ("CGM") will be provide by means of Paradigm Real-Time MMT-722 and Paradigm VEO MMT-754 Medtronic sensor-augmented insulin pumps. For monitoring the Sof-Sensor and MiniLink transmitter (Medtronic) will be use. Each sensor will be use for 6 days. CGM will be use for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month.

Procedure: Screening for Complications
To assess diabetic retinopathy a fundoscopy will be held. Diabetic nephropathy will be assessed by microalbuminuria screening, serum creatinine evaluation and calculation of CKD-EPI glomerular filtration rate. Diabetic neuropathy will be assessed by all kinds of sensitivity evaluation (vibrating, tactile, temperature).

Procedure: Glycaemic control assessment
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.

Procedure: QoL assessment

For Quality of Life ("QoL") assessment will be used the following validated questionnaires (in Russian):

  1. The Medical Outcomes Study 36-Item Short Form Health Survey - SF-36.
  2. The Audit of the Diabetes-Dependent Quality of Life - ADDQoL (С. Bradley et al, 1999, adjusted by Starostina E.G., 2003).

Procedure: Knowledge assessment
For the knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used. Maximum score equals 37 grades; the satisfactory level of knowledge is scored 27.

Active Comparator: SAP + Standard Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) 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.
Device: CSII
The intensified insulin therapy by means of continuous subcutaneous insulin infusion will be provide by Medtronic insulin pumps: Paradigm MMT-712/715, Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.

Device: CGM-RT
Continuous glucose monitoring ("CGM") will be provide by means of Paradigm Real-Time MMT-722 and Paradigm VEO MMT-754 Medtronic sensor-augmented insulin pumps. For monitoring the Sof-Sensor and MiniLink transmitter (Medtronic) will be use. Each sensor will be use for 6 days. CGM will be use for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month.

Procedure: Screening for Complications
To assess diabetic retinopathy a fundoscopy will be held. Diabetic nephropathy will be assessed by microalbuminuria screening, serum creatinine evaluation and calculation of CKD-EPI glomerular filtration rate. Diabetic neuropathy will be assessed by all kinds of sensitivity evaluation (vibrating, tactile, temperature).

Procedure: Glycaemic control assessment
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.

Procedure: QoL assessment

For Quality of Life ("QoL") assessment will be used the following validated questionnaires (in Russian):

  1. The Medical Outcomes Study 36-Item Short Form Health Survey - SF-36.
  2. The Audit of the Diabetes-Dependent Quality of Life - ADDQoL (С. Bradley et al, 1999, adjusted by Starostina E.G., 2003).

Procedure: Knowledge assessment
For the knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used. Maximum score equals 37 grades; the satisfactory level of knowledge is scored 27.

Experimental: CSII + Group Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
Behavioral: Education by structured programme
Thе structured programme was developed in Endocrinology Research Centre. It is based on the following principles: education in group setting, using structured program; intensive insulin treatment using insulin pumps; self-adjustment of insulin dose and pump settings; intensive self-monitoring of blood glucose, including continuous glucose monitoring in real-time ("CGM-RT"); flexible physical activities and meals regimen (liberal diet, based on carbohydrates account using bread units; possible shifts of meals schedule and volume supported by appropriate treatment adjustment). Duration of education course - 8 days (35-37 hours); planned group volume is 7-10 patients.

Device: CSII
The intensified insulin therapy by means of continuous subcutaneous insulin infusion will be provide by Medtronic insulin pumps: Paradigm MMT-712/715, Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.

Procedure: Screening for Complications
To assess diabetic retinopathy a fundoscopy will be held. Diabetic nephropathy will be assessed by microalbuminuria screening, serum creatinine evaluation and calculation of CKD-EPI glomerular filtration rate. Diabetic neuropathy will be assessed by all kinds of sensitivity evaluation (vibrating, tactile, temperature).

Procedure: Glycaemic control assessment
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.

Procedure: QoL assessment

For Quality of Life ("QoL") assessment will be used the following validated questionnaires (in Russian):

  1. The Medical Outcomes Study 36-Item Short Form Health Survey - SF-36.
  2. The Audit of the Diabetes-Dependent Quality of Life - ADDQoL (С. Bradley et al, 1999, adjusted by Starostina E.G., 2003).

Procedure: Knowledge assessment
For the knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used. Maximum score equals 37 grades; the satisfactory level of knowledge is scored 27.

Active Comparator: CSII + Standard Education
Patients will be transferred from MDI to CSII 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.
Device: CSII
The intensified insulin therapy by means of continuous subcutaneous insulin infusion will be provide by Medtronic insulin pumps: Paradigm MMT-712/715, Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.

Procedure: Screening for Complications
To assess diabetic retinopathy a fundoscopy will be held. Diabetic nephropathy will be assessed by microalbuminuria screening, serum creatinine evaluation and calculation of CKD-EPI glomerular filtration rate. Diabetic neuropathy will be assessed by all kinds of sensitivity evaluation (vibrating, tactile, temperature).

Procedure: Glycaemic control assessment
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.

Procedure: QoL assessment

For Quality of Life ("QoL") assessment will be used the following validated questionnaires (in Russian):

  1. The Medical Outcomes Study 36-Item Short Form Health Survey - SF-36.
  2. The Audit of the Diabetes-Dependent Quality of Life - ADDQoL (С. Bradley et al, 1999, adjusted by Starostina E.G., 2003).

Procedure: Knowledge assessment
For the knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used. Maximum score equals 37 grades; the satisfactory level of knowledge is scored 27.




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 4 month after CSII initiation ]
    HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.


Secondary Outcome Measures :
  1. Severe Hypoglycaemia Frequency [ Time Frame: within 4 month of the study ]
    Severe 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.

  2. Quality of Life (ADDQoL Questionnaire) [ Time Frame: 4 month after CSII initiation ]

    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).


  3. Nonsevere Hypoglycaemia Frequency [ Time Frame: within 4 month of the study ]
    Nonsevere 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.

  4. Glycaemic Variability [ Time Frame: within 4 month of the study ]
    Several 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.

  5. Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use) [ Time Frame: within 4 month of the study ]
    Treatment compliance evaluation was based on frequency of SMBG and bolus calculator use as one of the factors mediating achievement of target plasma glucose level.

  6. Quality of Life (SF36 Questionnaire) [ Time Frame: 4 months after CSII initiation ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus;
  • Disease duration > 1 year;
  • Patients informed consent, approving participation and completion of questionnaires.

Exclusion Criteria:

  • Severe late diabetic complications (diabetic foot syndrome, painful neuropathy, autonomic neuropathy, significant loss of vision, glomerular filtration rate < 30 ml/min/1.73 m2);
  • Pregnancy;
  • Severe concomitant diseases;
  • Known psychic disorders and/or treatment with psychotropic medicines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423993


Sponsors and Collaborators
Endocrinology Research Centre, Moscow
Investigators
Study Chair: Aleksandr Y Mayorov, MD,PhD Endocrinology Research Centre
Study Director: Marina V Shestakova, MD,PhD,Prof Endocrinology Research Centre
Principal Investigator: Lyudmila I Ibragimova, MD, PhD Endocrinology Research Centre

Additional Information:
Publications of Results:
Ibragimova LI, Filippov YI, Mayorov AY. Insulin pump therapy in type 1 diabetes mellitus: education effectiveness and quality of life. Diabetes mellitus 15(1):35-40, 2012. doi: 10.14341/2072-0351-5977

Other Publications:
Philippov YI. Continuous monitoring of blood glucose in the practice of endocrinologist. Obesity and metabolism 9(4):15-22, 2012. doi: 10.14341/2071-8713-5124
Filippov YI, Pekareva EV, Mayorov AY. Selected aspects of insulin pump therapy and continuous glucose monitoring in real time ( in relation to the letter of E.D.Gorbachev). Diabetes mellitus 13(4):119-124, 2010. doi: 10.14341/2072-0351-6074

Responsible Party: Ibragimova Lyudmila, MD, PhD, Endocrinology Research Centre, Moscow
ClinicalTrials.gov Identifier: NCT02423993     History of Changes
Other Study ID Numbers: 101-01-2010
First Posted: April 22, 2015    Key Record Dates
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016
Last Verified: December 2015

Keywords provided by Ibragimova Lyudmila, Endocrinology Research Centre, Moscow:
Type 1 diabetes mellitus
Continuous subcutaneous insulin infusion
Quality of life
Therapeutic education
Insulin pump

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs