Health Care for Type 1 Diabetes in Developing World

Type 1 Diabetes Clinical Trial

Official title:

Evaluation of Differing Type 1 Diabetes Regimens in Youth in the Developing World

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424046
• Other study ID #: RC4 pitt 1
• Secondary ID: RC4DK090809
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: December 4, 2014
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardRwanda: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study is a pilot 2-armed, randomized, open label, clinical trial evaluating the effectiveness of a basal approach to diabetes management as compared to the current standard treatment (regular/NPH).

Patients seen at the Association Rwandaise des Diabetiques (ARD) will be invited to participate in the study and consent will be obtained by the investigation team. This will continue until 40 patients have been enrolled at which time recruitment will be started at a provincial hospital, at which 10 further participants will be recruited. Participants will be consenting to 1) Randomization to basal or current insulin treatment arm and 2) Permission for use of clinical data for research.Participants will be followed every six months for a period of 24 months. The first 6 months will be a wash in period and participants will be randomised (1/1) to their treatments at the 6 month visit.

Description:

All participants will be provided with the consent form (that has been translated into the native language of Kinyarwandan) by the investigators and consent will be obtained from the participant if they are aged 18 and older or by parents/guardians if they are under 18 years. For those aged 14 - 17 years a child assent will be obtained. For those who are unable to read the consent form a patient advocate who will read this form to them and answer any questions a potential participant may have. Each person will have time and space to review all of the study information and they will be informed that participation is completely voluntary and that they will continue to receive their normal care if they do not wish to participate. At this visit the following data will be extracted from their clinical files by a research assistant under the supervision of Prof Kakoma:

At all 6 monthly visits (V1-V4), data from the participants' regular clinical visits (based on the annual evaluation form for the Life For a Child program) will be extracted. This includes HbA1c and microalbuminuria data collection, as well as documentation of: insulin regimen, incidents of severe hypo- and hyper-glycemia, symptoms of hyperglycemia, current schooling level, number of school days missed due to diabetes, self-rating of diabetes control, height, weight, blood pressure, and a basic neurological examination (vibratory sensation of great toe and monofilament testing). Information will be abstracted by research assistants from the National University of Rwanda (NUR), and education and management functions will be carried out by nurses from the ARD that will be trained by Drs Orchard and Edidin.

Each enrolled participant will be followed for a six month period post enrollment on their current treatment regimen so the impact of being enrolled in a study rather than an effect of their treatment, can be assessed.

All participants will be supplied with a glucose meter and sufficient strips to test daily. These results will also be made available to and reviewed by the ARD staff and will be used for further dose adjustment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 24 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes being treated by the Association Rwandese des Diabetiques

• Resident of Rwanda

Exclusion Criteria:

• life expectancy less than three years

• requiring additional diabetes therapy beyond the scope of the trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• basal insulin glargine
Individuals assigned to this arm will initially receive a basal insulin injection daily and gradually be introduced to meal time coverage of blood sugar with additional short acting insulin. Education will like wise proceed in a stepwise manner.
• standard therapy
Participants will continue with current mixed insulin treatment using NPH , or lente, and regular insulin .

Locations

Country	Name	City	State
Rwanda	Association Rwandese des Diabetiques	Kigali	Kigali Provence

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Association Rwandaise des Diabetiques, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National University, Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	The primary outcome is the level of blood sugar control after 1 years treatment as determined by the Hb A1c test	one year	Yes
Secondary	Microalbuminuria	Microalbuminuria, the leakage of abnormal amounts of protein in the urine is a major complication of type 1 diabetes and the prevalence of this in the two groups is a secondary outcome	one year	Yes