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

Endocrinology Research Centre, Moscow

Status: Completed

Conditions: Diabetes Mellitus, Type 1

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02423993

101-01-2010

Details and patient eligibility

About

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).

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 4 patient groups

SAP + Group Education

Experimental group

Description:

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.

Treatment:

Device: CSII

Procedure: Glycaemic control assessment

Device: CGM-RT

Procedure: Knowledge assessment

Procedure: QoL assessment

Procedure: Screening for Complications

Behavioral: Education by structured programme

SAP + Standard Education

Active Comparator group

Description:

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.

Treatment:

Device: CSII

Procedure: Glycaemic control assessment

Device: CGM-RT

Procedure: Knowledge assessment

Procedure: QoL assessment

Procedure: Screening for Complications

CSII + Group Education

Experimental group

Description:

Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.

Treatment:

Device: CSII

Procedure: Glycaemic control assessment

Procedure: Knowledge assessment

Procedure: QoL assessment

Procedure: Screening for Complications

Behavioral: Education by structured programme

CSII + Standard Education

Active Comparator group

Description:

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.

Treatment:

Device: CSII

Procedure: Glycaemic control assessment

Procedure: Knowledge assessment

Procedure: QoL assessment

Procedure: Screening for Complications