We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03362762
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

November 27, 2017
December 5, 2017
December 5, 2017
December 16, 2013
September 27, 2016   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe
Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
This study concerns the type 2 diabetes patients, followed by physicians in Guadeloupe.
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:
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
September 27, 2016
September 27, 2016   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Guadeloupe
 
 
NCT03362762
RNI-PAP-913379
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Centre Hospitalier Universitaire de Pointe-a-Pitre
Centre Hospitalier Universitaire de Pointe-a-Pitre
Not Provided
Principal Investigator: Pauline NOUVIER KANGAMBEGA, medicine degree, diabetes Hospital University Center of Pointe-à-Pitre
Centre Hospitalier Universitaire de Pointe-a-Pitre
November 2017