Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Behavioral: Education by structured programme
Device: CSII
Procedure: Screening for Complications
Device: CGM-RT
Procedure: Glycaemic control assessment
Procedure: QoL assessment
Procedure: Knowledge assessment

Registration Number: NCT02423993

Lead Sponsor: 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).

Detailed Description: The study will include 80 patients with type 1 diabetes that will be transferred from multiple daily injection (MDI) regimen to continuous subcutaneous insulin infusion (CSII). All patients will be divided into 2 groups: 1) structured education group (n=40) and 2) control group (n=40).

Patients from structured education group will be transferred from MDI to CSII using special structured education program for type 1 diabetes patients on insulin pump therapy. Before the transferring to CSII the patients from this group will be randomized in two subgroups, depending on type of blood glucose control: patients which will use CSII and self-monitoring of blood glucose (SMBG) (n=20) or patients which will use sensor-augmented pump (SAP) (n=20).

Follow-up duration in structured education group will be 4 months; follow-up visits included treatment adjustment, glucose data review and and collection of data on adverse events every 4 weeks. Between visits, communication with clinicians will be initiated at the discretion of the patient.

The control group will include patients with type 1 diabetes using CSII during 4-6 months before. The patients from this group will be divided in two subgroups, depending on type of self blood glucose control: patients using CSII (n=20) and SMBG or patients using SAP (n=20). In this group patients should be transferred to CSII 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 in intensive diabetes management, including carbohydrate counting, the administration of correction doses of insulin and technical aspects of CSII and self glucose control by continuous glucose monitoring in real-time ("CGM-RT").

All patients will provide written informed consent.

Diabetes-management software (CareLink Therapy Management System for Diabetes-Clinical, Medtronic) will be used for glucose data review including frequency of hypoglycemia, assessment of frequency of bolus calculator use.

Diaries of self-control will be analysed for glucose data review.

The level of knowledge about the basics of diabetes self-management will be assessed using a standard questionnaire for patients with type 1 diabetes.

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).

Patients from structured education group will complete the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group will complete the Questionnaires during the enrollment.

Assessment of diabetes complications will be held before and 4 months after transferring to CSII in structured education group and at the time of enrollment in control group.

For the knowledge assessment of disease management will be used standard Questionnaire for patients with type 1 diabetes. Maximum score equals 37 grades; the satisfactory level of knowledge is scored 27. Patients from the structural education group will complete the Questionnaire prior to conversion to CSII regimen and the education course and after 4 months of the follow up. Patients from the control group will complete the Questionnaire during enrollment.

Statistical analysis. Statistica (StatSoft Inc., USA, version 8.0) software will be used for data processing. The following descriptive statistical parameters will be used: median, inter-quartile interval (Me \[25;75\]) and mass share (%). Non- parametric criteria will be used used for non-normalized distribution (Mann - Whitney U-criterion for paired comparison of independent samples). The χ2 criterion was used for comparison of parameters distribution in population samples. Non - parametric Spearman's correlation will be used for correlation analysis. Standard deviation (M±SD) will be used to evaluate the rate of hypoglycemia events, frequency of plasma glucose level self-control, utilization of bolus calculator, plasma glucose level variability, and for certain items of QoL Questionnaires. A P value of less than 0.05 will be considered to indicate statistical significance for comparisons of the primary outcome, baseline characteristics, and safety.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 77

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAP + Group Education	QoL assessment	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.
CSII + Group Education	Screening for Complications	Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
SAP + Group Education	Education by structured programme	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.
CSII + Group Education	CSII	Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
SAP + Group Education	Screening for Complications	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.
SAP + Standard Education	QoL assessment	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.
CSII + Group Education	Glycaemic control assessment	Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
CSII + Group Education	QoL assessment	Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
SAP + Group Education	CGM-RT	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.
SAP + Standard Education	CGM-RT	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.
SAP + Standard Education	Screening for Complications	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.
SAP + Standard Education	Knowledge assessment	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.
SAP + Group Education	CSII	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.
SAP + Group Education	Glycaemic control assessment	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.
SAP + Group Education	Knowledge assessment	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.
SAP + Standard Education	CSII	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.
SAP + Standard Education	Glycaemic control assessment	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.
CSII + Standard Education	Screening for Complications	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.
CSII + Standard Education	Glycaemic control assessment	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.
CSII + Group Education	Education by structured programme	Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
CSII + Standard Education	CSII	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.
CSII + Group Education	Knowledge assessment	Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
CSII + Standard Education	Knowledge assessment	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.
CSII + Standard Education	QoL assessment	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.

Primary Outcome Measures

Name	Time	Method
HbA1c	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

Name	Time	Method
Glycaemic Variability	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.
Quality of Life (ADDQoL Questionnaire)	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).
Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)	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.
Quality of Life (SF36 Questionnaire)	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.
Severe Hypoglycaemia Frequency	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.
Nonsevere Hypoglycaemia Frequency	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.