Clinical trial NCT02423993: Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy
Official title: Efficiency Assessment of the Structured Education Program for Type 1 Diabetes Patients on Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 diabetes mellitus
Continuous subcutaneous insulin infusion
Quality of life
Therapeutic education
Insulin pump
Lead sponsor: Endocrinology Research Centre, Moscow
Sponsor class: OTHER_GOV
First posted: 2015-04-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: HbA1c
timeFrame: 4 month after CSII initiation
Secondary outcomes:
measure: Severe Hypoglycaemia Frequency
timeFrame: within 4 month of the study
measure: Quality of Life (ADDQoL Questionnaire)
timeFrame: 4 month after CSII initiation
measure: Nonsevere Hypoglycaemia Frequency
timeFrame: within 4 month of the study
measure: Glycaemic Variability
timeFrame: within 4 month of the study
measure: Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)
timeFrame: within 4 month of the study
measure: Quality of Life (SF36 Questionnaire)
timeFrame: 4 months after CSII initiation
Other outcomes:
Locations:
Study officials:
affiliation: Endocrinology Research Centre
name: Aleksandr Y Mayorov, MD,PhD
role: STUDY_CHAIR
affiliation: Endocrinology Research Centre
name: Marina V Shestakova, MD,PhD,Prof
role: STUDY_DIRECTOR
affiliation: Endocrinology Research Centre
name: Lyudmila I Ibragimova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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