Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-05-31
2014-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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basal insulin approach
Participants will be treated primarily with a daily basal insulin injection ( glargine) with later introduction of prandial coverage with a shortacting insulin.
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 current mixed insulin management and education
standard therapy
Participants will continue with current mixed insulin treatment using NPH , or lente, and regular insulin .
Interventions
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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 .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Resident of Rwanda
Exclusion Criteria
* requiring additional diabetes therapy beyond the scope of the trial
1 Year
24 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National University, Rwanda
OTHER
Association Rwandaise des Diabetiques
UNKNOWN
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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Trevor J Orchard, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Association Rwandese des Diabetiques
Kigali, Kigali Provence, Rwanda
Countries
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Other Identifiers
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RC4 pitt 1
Identifier Type: -
Identifier Source: org_study_id