NCT01498367

Brief Summary

To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large tertiary care center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

December 21, 2011

Last Update Submit

February 16, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2Telemedicine

Outcome Measures

Primary Outcomes (2)

  • Health related quality of life of the patients measured by the SF-36 version 2 questionnaire

    12 months minimum- at the entry point of the intervention and the end.

  • HbA1c levels

    Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)

    12 months minimum - at the entry point and every 3 months.

Secondary Outcomes (5)

  • Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"

    12 months minimum- at the entry point of the intervention and the end.

  • Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)

    12 months minimum- at the entry point of the intervention and the end.

  • Nutrition habits assessed by validated questionnaire.

    12 months minimum- at the entry point of the intervention and the end.

  • Patients' Acceptance-Satisfaction measured by the WSD Questionnaire

    at 2nd and at 12th month

  • Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)

    12 months minimum

Study Arms (2)

Usual care

NO INTERVENTION

Participants in the control group receive usual care. Usual care consists of regular visits to the specialist when required. In the occasion of the visit, HbA1c and glucose measurements are performed and the current oral or insulin therapy is modified if necessary. Patients also receive basic education in the management of diabetes.

Telemonitoring of diabetes 2 patients

EXPERIMENTAL

Patients will have one educational visit to set up the system and explain how it works. Patients will download their measurements from their tele-glucose meter to their mobile phone and the data will be transferred to the regional database. The care team (a nurse specially trained and the allocated physician) will regularly access the patient's home diary, and will provide the appropriate counselling and medication changes as frequently as necessary. In addition to blood glucose measurements, routine questions about symptoms and eventual difficulties related to diabetes as well as diabetic management will be routinely captured and reported.

Procedure: Telemonitoring of patients with diabetes type 2

Interventions

Telemonitoring of patients with diabetes type 2PROCEDURE

Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter

Telemonitoring of diabetes 2 patients

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of type 2 Diabetes
  • HbA1c \> 53 mmol/mol (7.0 % according to NGSP)
  • Capability to use the devices provided
  • Being cognitively able to participate
  • Capability of filling in questionnaires in german or greek language
  • Absence of severe comorbidity prevalent on diabetes with life expectancy \< 12 months

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa

Larissa, Thessaly, 41110, Greece

Location

Related Publications (3)

  • Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 2009 Oct;11(10):913-30. doi: 10.1111/j.1463-1326.2009.01057.x. Epub 2009 Jun 16.

    PMID: 19531058BACKGROUND

  • Klonoff DC. Diabetes and telemedicine: is the technology sound, effective, cost-effective, and practical? Diabetes Care. 2003 May;26(5):1626-8. doi: 10.2337/diacare.26.5.1626. No abstract available.

    PMID: 12716831BACKGROUND

  • Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. doi: 10.1111/j.1365-2753.2006.00686.x.

    PMID: 17378871BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Georgios Koukoulis, MD, PhD

    Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor, Director of the Endocrinology and Metabolic Diseases Department, University Hospital of Larissa

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 23, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

GR(1)