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Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe (DT2IT)

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ClinicalTrials.gov Identifier: NCT03362762
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Pointe-a-Pitre

Brief Summary:

Type 2 diabetes is a major problem of public health in the French West Indies, with an estimated prevalence of 8%, twice more than in France. In Guadeloupe, according to the statistical data of hospital morbidity in 2004, 2643 hospital stays were diagnosed with diabetes. These cases mainly concerned woman (62%) and the elderly, from 45 to 74 years old (67%).

The main objective of this research is to describe the insulin protocol used in Guadeloupe for treated type 2 diabetes patients and their characteristics:

  • The duration of the type 2 diabetes
  • Time elapsing between the diagnosis and the treatment by insulin
  • Where the follow up care took place
  • Existence of complications

Secondary objectives were to describe the link between the HbA1c rate and the insulin therapy protocol. And also to present the main inconveniences expressed by patients and their degree of autonomy.


Condition or disease Intervention/treatment
Type 2 Diabetes Treated With Insulin Other: Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients:

Detailed Description:

Nowadays the set up for insulin treatment is available in general practitioners' offices. However, it is restrained by the reticence of patients and physicians. For type 2 diabetes, insulin therapy is well managed and there is ongoing progress. But there are still some questions about the effect of the treatment in the everyday life of patients: culture, fear, material resources, necessity of education.

Ignorance and prejudices on insulin injection are still prevalent and often it delays for more than a year the time when patients have to switch an insulin treatment for unbalanced chronic disorder.

Type 2 diabetes patients think that the treatment is heavy, can lead to serious hypoglycemia, is uncomfortable for family and can cause fear.

Education of the patients can reduce ignorance and prejudices about insulin treatment.

Nowadays studies show that diabetes patients want to be more involved in the decisions linked to their treatment which impact their perception of the disease and the treatment.

Auto measurement of glycaemia can help the patient better manage his disease and make him understand the importance of controlling his glycaemia levels.

This study could allow to:

  • Offer a new care organization for a better use of resources (network, patient therapeutic education…)
  • Set up adequate training for professionals and for patients being cared for in medical offices.
  • Improve the glycemic balance of patients and slower the growth of degenerative complications.

Study Type : Observational
Actual Enrollment : 205 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe
Actual Study Start Date : December 16, 2013
Actual Primary Completion Date : September 27, 2016
Actual Study Completion Date : September 27, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients:
    The physician or the endocrinologist will see the patient during his consultation. The pharmacist will see the patient when he goes to the pharmacy for an insulin treatment. In each case, the patient will be informed about the study, about the medical data that will be collected anonymously. The date will be strictly confidential and under medical secrecy. Then the patient will meet the physician during another consultation at the University Hospital Center of Guadeloupe, in order to collect information's on a questionnaire. Otherwise, the physician can meet the patient at his home, in case he can't move to the University Hospital Center of Guadeloupe.


Primary Outcome Measures :
  1. Characteristic of type 2 diabetes patients, treated with insulin in Guadeloupe [ Time Frame: Trough study completion, an average of 2 years ]

    A descriptive analysis will be done on the population concerned by the study, for the socio demographic, clinical and therapeutic characteristics.

    • the duration of the type 2 diabetes,
    • time elapsing between the diagnostic and the treatment by insulin,
    • place of the follow up care,
    • existence of complications.


Secondary Outcome Measures :
  1. Describe the relation between the rate of HbAC and the plan of insulinothérapie [ Time Frame: Trough study completion, an average of 2 years ]
    Sreening of HbAC



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study concerns the type 2 diabetes patients, followed by physicians in Guadeloupe.
Criteria

Inclusion Criteria:

  • Men or woman
  • Age ≥ 18 years old
  • Patient with type 2 diabetes, treated with insulin for at least one year
  • Patient accepting to participate to the study

Exclusion Criteria:

• Pregnant or breastfeeding woman


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362762


Locations
Guadeloupe
University Hospital Center of Pointe-à-Pitre
Pointe-à-Pitre, Guadeloupe, 97159
Sponsors and Collaborators
Centre Hospitalier Universitaire de Pointe-a-Pitre
Investigators
Principal Investigator: Pauline NOUVIER KANGAMBEGA, medicine degree, diabetes Hospital University Center of Pointe-à-Pitre

Responsible Party: Centre Hospitalier Universitaire de Pointe-a-Pitre
ClinicalTrials.gov Identifier: NCT03362762     History of Changes
Other Study ID Numbers: RNI-PAP-913379
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Pointe-a-Pitre:
Type 2 diabetes
insulin
Hb1Ac
glycemia
Guadeloupe

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs