Back to results

Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months

Primary Purpose

Diabetes Complications

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

GuardianR

About this trial

This is an interventional diagnostic trial for Diabetes Complications focused on measuring glucose, diabetes, glycemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject major, from 18 to 70 years old
Diabetes of type 1 defined according to the criteria of American Diabetes Association
Insulinic treatment for at least 12 months
Understood HbA1C enters 6,5 and 9,5 %

Exclusion Criteria:

Minor subjects or under guardianship
Unbalance kétosis current or recent
Pregnancy
Incapacitated to participate weekly complete educational in the functional insulin-therapy,
Evolutionary severe general disease
Psychiatric confusions
Unbalance chronic (HbA1c > 9,5 %) connected to an absence of adapted coverage or to abnormal behaviors
Pathology making not interpretable the rate of HbA1c (hemoglobinopathy, anemia)

Sites / Locations

CHU timone

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

This arm will benefit from the nonstop measure of the subcutaneous glucose during the hospitalization and the week on returning to the place of residence,

Outcomes

Primary Outcome Measures

The HbA1c, the witness of the quality of the metabolic balance, in 6 and 12 months. We shall compare the deltae of HbA1c between the period of inclusion and 6 and 12 months following the training course in the "fonctional" insulin therapy

Secondary Outcome Measures

Full Information

NCT ID

NCT00682903

First Posted

March 5, 2008

Last Updated

August 27, 2014

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT00682903

Brief Title

Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of the project is to evaluate advantages from the use of a bearable continuous interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic patients dedicated to functional insulin therapy teaching. This concept of intensified treatment is based on testing and explanation of simplified decision making algorithms to adapt insulin dose to every true life conditions. As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.

Detailed Description

Two groups of 60 patients (experimental and control groups) will be followed and evaluated at 6 and 12 months. We do think that this new tool would facilitate education of patients and lead further to a better glycemic control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Complications

Keywords

glucose, diabetes, glycemia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

This arm will benefit from the nonstop measure of the subcutaneous glucose during the hospitalization and the week on returning to the place of residence,

Intervention Type

Device

Intervention Name(s)

GuardianR

Intervention Description

As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.

Primary Outcome Measure Information:

Title

Time Frame

glycemia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject major, from 18 to 70 years old Diabetes of type 1 defined according to the criteria of American Diabetes Association Insulinic treatment for at least 12 months Understood HbA1C enters 6,5 and 9,5 % Exclusion Criteria: Minor subjects or under guardianship Unbalance kétosis current or recent Pregnancy Incapacitated to participate weekly complete educational in the functional insulin-therapy, Evolutionary severe general disease Psychiatric confusions Unbalance chronic (HbA1c > 9,5 %) connected to an absence of adapted coverage or to abnormal behaviors Pathology making not interpretable the rate of HbA1c (hemoglobinopathy, anemia)

Facility Information:

Facility Name

CHU timone

City

Marseille

State/Province

Bouches du Rhone

ZIP/Postal Code

13005

Country

France

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs