Type 2 Diabetes Treated With InsulinDT2ITNCT03362762
Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe
An observational study of Type 2 Diabetes Treated With Insulin, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients:
- How many people
- 205 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 16 Dec 2013to 27 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study concerns the type 2 diabetes patients, followed by physicians in Guadeloupe.
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
University Hospital Center of Pointe-à-Pitre
Pointe-à-Pitre, 97159
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients:
- Keywords
- Type 2 diabetes, insulin, Hb1Ac, glycemia, Guadeloupe
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients:Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristic of type 2 diabetes patients, treated with insulin in Guadeloupe
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.
Measured: Trough study completion, an average of 2 years
Secondary outcomes (1)
Describe the relation between the rate of HbAC and the plan of insulinothérapie
Sreening of HbAC
Measured: Trough study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start16 Dec 2013
- Primary completion27 Sep 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline NOUVIER KANGAMBEGA, medicine degree, diabetes, Principal investigator, Hospital University Center of Pointe-à-Pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362762
- Sponsor's protocol ID
- RNI-PAP-913379
- Acronym
- DT2IT
- Status last verified
- Nov 2017
- First submitted
- 27 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe
- ClinicalTrials.gov ID
- NCT03362762
- Acronym / sponsor ID
- DT2IT / RNI-PAP-913379
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Type 2 diabetes, insulin, Hb1Ac, glycemia, Guadeloupe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns the type 2 diabetes patients, followed by physicians in Guadeloupe.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Describe the relation between the rate of HbAC and the plan of insulinothérapie
Time frame: Trough study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline NOUVIER KANGAMBEGA, medicine degree, diabetes principal investigator
Hospital University Center of Pointe-à-Pitre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Treated With Insulin, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristic of type 2 diabetes patients, treated with insulin in Guadeloupe (time frame: Trough study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.