NCT02423993

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 11, 2016

Completed
Last Updated

January 11, 2016

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

April 19, 2015

Results QC Date

August 4, 2015

Last Update Submit

December 7, 2015

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes mellitusContinuous subcutaneous insulin infusionQuality of lifeTherapeutic educationInsulin pump

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.

    4 month after CSII initiation

Secondary Outcomes (6)

  • Severe Hypoglycaemia Frequency

    within 4 month of the study

  • Quality of Life (ADDQoL Questionnaire)

    4 month after CSII initiation

  • Nonsevere Hypoglycaemia Frequency

    within 4 month of the study

  • Glycaemic Variability

    within 4 month of the study

  • Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)

    within 4 month of the study

  • +1 more secondary outcomes

Study Arms (4)

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.

Behavioral: Education by structured programmeDevice: CSIIDevice: CGM-RTProcedure: Screening for ComplicationsProcedure: Glycaemic control assessmentProcedure: QoL assessmentProcedure: 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.

Device: CSIIDevice: CGM-RTProcedure: Screening for ComplicationsProcedure: Glycaemic control assessmentProcedure: QoL assessmentProcedure: 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.

Behavioral: Education by structured programmeDevice: CSIIProcedure: Screening for ComplicationsProcedure: Glycaemic control assessmentProcedure: QoL assessmentProcedure: 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.

Device: CSIIProcedure: Screening for ComplicationsProcedure: Glycaemic control assessmentProcedure: QoL assessmentProcedure: Knowledge assessment

Interventions

Education by structured programmeBEHAVIORAL

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.

CSII + Group EducationSAP + Group Education
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.

CSII + Group EducationCSII + Standard EducationSAP + Group EducationSAP + Standard Education
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.

SAP + Group EducationSAP + Standard Education
Screening for ComplicationsPROCEDURE

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).

CSII + Group EducationCSII + Standard EducationSAP + Group EducationSAP + Standard Education
Glycaemic control assessmentPROCEDURE

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.

CSII + Group EducationCSII + Standard EducationSAP + Group EducationSAP + Standard Education
QoL assessmentPROCEDURE

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).

CSII + Group EducationCSII + Standard EducationSAP + Group EducationSAP + Standard Education
Knowledge assessmentPROCEDURE

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.

CSII + Group EducationCSII + Standard EducationSAP + Group EducationSAP + Standard Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes mellitus;
  • Disease duration \> 1 year;
  • Patients informed consent, approving participation and completion of questionnaires.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • 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.

    PMID: 8040759BACKGROUND

  • Bradley 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.

    PMID: 12324988BACKGROUND

  • Clark 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.

    PMID: 18779034BACKGROUND

  • Corriveau 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.

    PMID: 18774996BACKGROUND

  • Gross 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.

    PMID: 12828818BACKGROUND

  • DAFNE 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.

    PMID: 12364302BACKGROUND

  • Home 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.

    PMID: 6112654BACKGROUND

  • Lauritzen T, Pramming S, Deckert T, Binder C. Pharmacokinetics of continuous subcutaneous insulin infusion. Diabetologia. 1983 May;24(5):326-9. doi: 10.1007/BF00251817.

    PMID: 6347780BACKGROUND

  • Ludwig-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.

    PMID: 22128781BACKGROUND

  • Misso 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.

    PMID: 20091571BACKGROUND

  • Nixon 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.

    PMID: 21284474BACKGROUND

  • Pedersen-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.

    PMID: 15386817BACKGROUND

  • Pickup 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.

    PMID: 340000BACKGROUND

  • Rubin 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.

    PMID: 21217102BACKGROUND

  • Rubin 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.

    PMID: 10441043BACKGROUND

  • Riveline JP. Is continuous glucose monitoring (CGM) for everyone? To whom should CGM be prescribed and how? Diabetes Metab. 2011 Dec;37 Suppl 4:S80-4. doi: 10.1016/S1262-3636(11)70971-5.

    PMID: 22208716BACKGROUND

  • Schwartz FL, Guo A, Marling CR, Shubrook JH. Analysis of use of an automated bolus calculator reduces fear of hypoglycemia and improves confidence in dosage accuracy in type 1 diabetes mellitus patients treated with multiple daily insulin injections. J Diabetes Sci Technol. 2012 Jan 1;6(1):150-2. doi: 10.1177/193229681200600118.

    PMID: 22401333BACKGROUND

  • Shashaj B, Busetto E, Sulli N. Benefits of a bolus calculator in pre- and postprandial glycaemic control and meal flexibility of paediatric patients using continuous subcutaneous insulin infusion (CSII). Diabet Med. 2008 Sep;25(9):1036-42. doi: 10.1111/j.1464-5491.2008.02549.x.

    PMID: 18937673BACKGROUND

  • Wu YP, Graves MM, Roberts MC, Mitchell AC. Is insulin pump therapy better than injection for adolescents with diabetes? Diabetes Res Clin Pract. 2010 Aug;89(2):121-5. doi: 10.1016/j.diabres.2010.04.010. Epub 2010 May 21.

    PMID: 20488572BACKGROUND

  • Philippov YI. Continuous monitoring of blood glucose in the practice of endocrinologist. Obesity and metabolism 9(4):15-22, 2012. doi: 10.14341/2071-8713-5124

    BACKGROUND

  • Filippov YI, Pekareva EV, Mayorov AY. Selected aspects of insulin pump therapy and continuous glucose monitoring in real time ( in relation to the letter of E.D.Gorbachev). Diabetes mellitus 13(4):119-124, 2010. doi: 10.14341/2072-0351-6074

    BACKGROUND

  • Ibragimova LI, Filippov YI, Mayorov AY. Insulin pump therapy in type 1 diabetes mellitus: education effectiveness and quality of life. Diabetes mellitus 15(1):35-40, 2012. doi: 10.14341/2072-0351-5977

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Results Point of Contact

Title
Dr. Lyudmila Ibragimova
Organization
Endocrinology Research Centre, Moscow
doc_mila@mail.ru
+7 9266180811

Study Officials

  • Aleksandr Y Mayorov, MD,PhD

    Endocrinology Research Centre

    STUDY CHAIR

  • Marina V Shestakova, MD,PhD,Prof

    Endocrinology Research Centre

    STUDY DIRECTOR

  • Lyudmila I Ibragimova, MD, PhD

    Endocrinology Research Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 19, 2015

First Posted

April 22, 2015

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

February 1, 2013

Last Updated

January 11, 2016

Results First Posted

January 11, 2016

Record last verified: 2015-12