Diabetes Mellitus, Type 1EASEDIAPNCT02423993
Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy
A study testing Education by structured programme, CSII and CGM-RT in people with Diabetes Mellitus, Type 1, run by Endocrinology Research Centre, Moscow.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Education by structured programme, CSII and CGM-RT
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus;
- Disease duration > 1 year;
- Patients informed consent, approving participation and completion of questionnaires.
Who cannot join
- 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.
About this study
Official title: Efficiency Assessment of the Structured Education Program for Type 1 Diabetes Patients on Insulin Pump Therapy
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).
Read the 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):
- 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).
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
- Being tested
- Education by structured programme, CSII, CGM-RT, Screening for Complications, Glycaemic control assessment
- Keywords
- Type 1 diabetes mellitus, Continuous subcutaneous insulin infusion, Quality of life, Therapeutic education, Insulin pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education by structured programmeBehavioural
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.
CSIIDevice
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.
CGM-RTDevice
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.
Screening for ComplicationsProcedure or surgery
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).
Glycaemic control assessmentProcedure or surgery
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.
QoL assessmentProcedure or surgery
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).
Knowledge assessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SAP + Group Education | Experimental | 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. Receives: Behavioral: Education by structured programme; Device: CSII; Device: CGM-RT; Procedure: Screening for Complications; Procedure: Glycaemic control assessment; Procedure: QoL assessment; Procedure: Knowledge assessment |
| SAP + Standard Education | Active comparator | 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. Receives: Device: CSII; Device: CGM-RT; Procedure: Screening for Complications; Procedure: Glycaemic control assessment; Procedure: QoL assessment; Procedure: Knowledge assessment |
| CSII + Group Education | Experimental | Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program. Receives: Behavioral: Education by structured programme; Device: CSII; Procedure: Screening for Complications; Procedure: Glycaemic control assessment; Procedure: QoL assessment; Procedure: Knowledge assessment |
| CSII + Standard Education | Active comparator | 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. Receives: Device: CSII; Procedure: Screening for Complications; Procedure: Glycaemic control assessment; Procedure: QoL assessment; Procedure: Knowledge assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.
Measured: 4 month after CSII initiation
Secondary outcomes (6)
Severe Hypoglycaemia Frequency
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.
Measured: within 4 month of the study
Quality of Life (ADDQoL Questionnaire)
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).
Measured: 4 month after CSII initiation
Nonsevere Hypoglycaemia Frequency
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.
Measured: within 4 month of the study
Glycaemic Variability
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.
Measured: within 4 month of the study
Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)
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.
Measured: within 4 month of the study
Quality of Life (SF36 Questionnaire)
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.
Measured: 4 months after CSII initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocrinology Research Centre, Moscow
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ibragimova Lyudmila, Endocrinology Research Centre, Moscow
- Investigators
- Aleksandr Y Mayorov, MD,PhD, Study chair, Endocrinology Research CentreMarina V Shestakova, MD,PhD,Prof, Study director, Endocrinology Research CentreLyudmila I Ibragimova, MD, PhD, Principal investigator, Endocrinology Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423993
- Sponsor's protocol ID
- 101-01-2010
- Acronym
- EASEDIAP
- Status last verified
- Dec 2015
- First submitted
- 19 Apr 2015
- Last updated
- 11 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.
PubMed 8040759Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing quality of life. Diabetes Metab Res Rev. 2002 Sep-Oct;18 Suppl 3:S64-9. doi: 10.1002/dmrr.279.
PubMed 12324988Clark M. Diabetes self-management education: a review of published studies. Prim Care Diabetes. 2008 Sep;2(3):113-20. doi: 10.1016/j.pcd.2008.04.004. Epub 2008 Jun 25.
PubMed 18779034Corriveau EA, Durso PJ, Kaufman ED, Skipper BJ, Laskaratos LA, Heintzman KB. Effect of Carelink, an internet-based insulin pump monitoring system, on glycemic control in rural and urban children with type 1 diabetes mellitus. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):360-6. doi: 10.1111/j.1399-5448.2008.00363.x.
PubMed 18774996Gross TM, Kayne D, King A, Rother C, Juth S. A bolus calculator is an effective means of controlling postprandial glycemia in patients on insulin pump therapy. Diabetes Technol Ther. 2003;5(3):365-9. doi: 10.1089/152091503765691848.
PubMed 12828818DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ. 2002 Oct 5;325(7367):746. doi: 10.1136/bmj.325.7367.746.
PubMed 12364302Home PD, Pickup JC, Keen H, Alberti KG, Parsons JA, Binder C. Continuous subcutaneous insulin infusion: comparison of plasma insulin profiles after infusion or bolus injection of the mealtime dose. Metabolism. 1981 May;30(5):439-42. doi: 10.1016/0026-0495(81)90177-3.
PubMed 6112654Lauritzen T, Pramming S, Deckert T, Binder C. Pharmacokinetics of continuous subcutaneous insulin infusion. Diabetologia. 1983 May;24(5):326-9. doi: 10.1007/BF00251817.
PubMed 6347780Ludwig-Seibold CU, Holder M, Rami B, Raile K, Heidtmann B, Holl RW; DPV Science Initiative; German Working Group for insulin pump treatment in pediatric patients; German BMBF Competence Network Diabetes. Continuous glucose monitoring in children, adolescents, and adults with type 1 diabetes mellitus: analysis from the prospective DPV diabetes documentation and quality management system from Germany and Austria. Pediatr Diabetes. 2012 Feb;13(1):12-4. doi: 10.1111/j.1399-5448.2011.00835.x. Epub 2011 Nov 29.
PubMed 22128781Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005103. doi: 10.1002/14651858.CD005103.pub2.
PubMed 20091571Nixon R, Pickup JC. Fear of hypoglycemia in type 1 diabetes managed by continuous subcutaneous insulin infusion: is it associated with poor glycemic control? Diabetes Technol Ther. 2011 Feb;13(2):93-8. doi: 10.1089/dia.2010.0192.
PubMed 21284474Pedersen-Bjergaard U, Pramming S, Heller SR, Wallace TM, Rasmussen AK, Jorgensen HV, Matthews DR, Hougaard P, Thorsteinsson B. Severe hypoglycaemia in 1076 adult patients with type 1 diabetes: influence of risk markers and selection. Diabetes Metab Res Rev. 2004 Nov-Dec;20(6):479-86. doi: 10.1002/dmrr.482.
PubMed 15386817Pickup JC, Keen H, Parsons JA, Alberti KG. Continuous subcutaneous insulin infusion: an approach to achieving normoglycaemia. Br Med J. 1978 Jan 28;1(6107):204-7. doi: 10.1136/bmj.1.6107.204.
PubMed 340000Rubin RR, Borgman SK, Sulik BT. Crossing the technology divide: practical strategies for transitioning patients from multiple daily insulin injections to sensor-augmented pump therapy. Diabetes Educ. 2011 Jan-Feb;37 Suppl 1:5S-18S; quiz 19S-20S. doi: 10.1177/0145721710391107. Epub 2011 Jan 7.
PubMed 21217102Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999 May-Jun;15(3):205-18. doi: 10.1002/(sici)1520-7560(199905/06)15:33.0.co;2-o.
PubMed 10441043
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Assessment of the Structured Education Program for Type 1 Diabetes Patients on Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT02423993
- Acronym / sponsor ID
- EASEDIAP / 101-01-2010
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes mellitus, Continuous subcutaneous insulin infusion, Quality of life, Therapeutic education, Insulin pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Endocrinology Research Centre, MoscowOther government
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 11 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAP + Group Education | Experimental | Behavioral: Education by structured programme, Device: CSII, Device: CGM-RT, Procedure: Screening for Complications, Procedure: Glycaemic control assessment, Procedure: QoL assessment, Procedure: Knowledge assessmentPatients 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 | Active comparator | Device: CSII, Device: CGM-RT, Procedure: Screening for Complications, Procedure: Glycaemic control assessment, Procedure: QoL assessment, Procedure: Knowledge assessmentPatients 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 | Experimental | Behavioral: Education by structured programme, Device: CSII, Procedure: Screening for Complications, Procedure: Glycaemic control assessment, Procedure: QoL assessment, Procedure: Knowledge assessmentPatients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program. |
| CSII + Standard Education | Active comparator | Device: CSII, Procedure: Screening for Complications, Procedure: Glycaemic control assessment, Procedure: QoL assessment, Procedure: Knowledge assessmentPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes mellitus;
- Disease duration > 1 year;
- Patients informed consent, approving participation and completion of questionnaires.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education by structured programmeThе 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. | Behavioural | CSII + Group Education, SAP + Group Education |
| CSIIThe 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 | CSII + Group Education, CSII + Standard Education, SAP + Group Education, SAP + Standard Education |
| CGM-RTContinuous 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. | Device | SAP + Group Education, SAP + Standard Education |
| Screening for ComplicationsTo 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 or surgery | CSII + Group Education, CSII + Standard Education, SAP + Group Education, SAP + Standard Education |
| Glycaemic control assessmentGlycemic 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 or surgery | CSII + Group Education, CSII + Standard Education, SAP + Group Education, SAP + Standard Education |
| QoL assessmentFor 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 or surgery | CSII + Group Education, CSII + Standard Education, SAP + Group Education, SAP + Standard Education |
| Knowledge assessmentFor 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. | Procedure or surgery | CSII + Group Education, CSII + Standard Education, SAP + Group Education, SAP + Standard Education |
Primary outcome
HbA1c
Time frame: 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.
6 secondary outcomes
Severe Hypoglycaemia Frequency
Time frame: within 4 month of the study
Quality of Life (ADDQoL Questionnaire)
Time frame: 4 month after CSII initiation
Nonsevere Hypoglycaemia Frequency
Time frame: within 4 month of the study
Glycaemic Variability
Time frame: within 4 month of the study
Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)
Time frame: within 4 month of the study
Quality of Life (SF36 Questionnaire)
Time frame: 4 months after CSII initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8040759Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.
- Background: PubMed 12324988Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing quality of life. Diabetes Metab Res Rev. 2002 Sep-Oct;18 Suppl 3:S64-9. doi: 10.1002/dmrr.279.
- Background: PubMed 18779034Clark M. Diabetes self-management education: a review of published studies. Prim Care Diabetes. 2008 Sep;2(3):113-20. doi: 10.1016/j.pcd.2008.04.004. Epub 2008 Jun 25.
- Background: PubMed 18774996Corriveau EA, Durso PJ, Kaufman ED, Skipper BJ, Laskaratos LA, Heintzman KB. Effect of Carelink, an internet-based insulin pump monitoring system, on glycemic control in rural and urban children with type 1 diabetes mellitus. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):360-6. doi: 10.1111/j.1399-5448.2008.00363.x.
- Background: PubMed 12828818Gross TM, Kayne D, King A, Rother C, Juth S. A bolus calculator is an effective means of controlling postprandial glycemia in patients on insulin pump therapy. Diabetes Technol Ther. 2003;5(3):365-9. doi: 10.1089/152091503765691848.
- Background: PubMed 12364302DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ. 2002 Oct 5;325(7367):746. doi: 10.1136/bmj.325.7367.746.
- Background: PubMed 6112654Home PD, Pickup JC, Keen H, Alberti KG, Parsons JA, Binder C. Continuous subcutaneous insulin infusion: comparison of plasma insulin profiles after infusion or bolus injection of the mealtime dose. Metabolism. 1981 May;30(5):439-42. doi: 10.1016/0026-0495(81)90177-3.
- Background: PubMed 6347780Lauritzen T, Pramming S, Deckert T, Binder C. Pharmacokinetics of continuous subcutaneous insulin infusion. Diabetologia. 1983 May;24(5):326-9. doi: 10.1007/BF00251817.
- Background: PubMed 22128781Ludwig-Seibold CU, Holder M, Rami B, Raile K, Heidtmann B, Holl RW; DPV Science Initiative; German Working Group for insulin pump treatment in pediatric patients; German BMBF Competence Network Diabetes. Continuous glucose monitoring in children, adolescents, and adults with type 1 diabetes mellitus: analysis from the prospective DPV diabetes documentation and quality management system from Germany and Austria. Pediatr Diabetes. 2012 Feb;13(1):12-4. doi: 10.1111/j.1399-5448.2011.00835.x. Epub 2011 Nov 29.
- Background: PubMed 20091571Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005103. doi: 10.1002/14651858.CD005103.pub2.
- Background: PubMed 21284474Nixon R, Pickup JC. Fear of hypoglycemia in type 1 diabetes managed by continuous subcutaneous insulin infusion: is it associated with poor glycemic control? Diabetes Technol Ther. 2011 Feb;13(2):93-8. doi: 10.1089/dia.2010.0192.
- Background: PubMed 15386817Pedersen-Bjergaard U, Pramming S, Heller SR, Wallace TM, Rasmussen AK, Jorgensen HV, Matthews DR, Hougaard P, Thorsteinsson B. Severe hypoglycaemia in 1076 adult patients with type 1 diabetes: influence of risk markers and selection. Diabetes Metab Res Rev. 2004 Nov-Dec;20(6):479-86. doi: 10.1002/dmrr.482.
- Endocrinology Research CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandr Y Mayorov, MD,PhD study chair
Endocrinology Research Centre
Marina V Shestakova, MD,PhD,Prof study director
Endocrinology Research Centre
Lyudmila I Ibragimova, MD, PhD principal investigator
Endocrinology Research Centre
Questions about this trial
What is this clinical trial studying?
A study testing Education by structured programme, CSII and CGM-RT in people with Diabetes Mellitus, Type 1, run by Endocrinology Research Centre, Moscow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 4 month after CSII initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423993, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.