Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): Education by structured programme; CSII; CGM-RT; Screening for Complications; Glycaemic control assessment; QoL assessment; Knowledge assessment
Intervention type(s): Behavioral; Device; Device; Procedure; Procedure; Procedure; Procedure
Intervention description(s): 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.; 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.; 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.; 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).; 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.; For Quality of Life ("QoL") assessment will be used the following validated questionnaires (in Russian):
The Medical Outcomes Study 36-Item Short Form Health Survey - SF-36.
The Audit of the Diabetes-Dependent Quality of Life - ADDQoL (С. Bradley et al, 1999, adjusted by Starostina E.G., 2003).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus; Continuous subcutaneous insulin infusion; Quality of life; Therapeutic education; Insulin pump