NCT02423993

Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy

Efficiency Assessment of the Structured Education Program for Type 1 Diabetes Patients on Insulin Pump Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Endocrinology Research Centre, Moscow · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-10-01
• Completion: 2013-02-01
• First posted: 2015-04-22
• Last updated: 2016-01-11
• Results posted: 2016-01-11