Health Care for Type 1 Diabetes in Developing World

NCT01424046 | Completed DMC

• 2 other identifiers: RC4 pitt 1RC4DK090809
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; basal insulin; developing world; comparative effectiveness

Outcome Measures

Primary Outcomes (1)

• HbA1c

  The primary outcome is the level of blood sugar control after 1 years treatment as determined by the Hb A1c test

  one year

Secondary Outcomes (1)

• Microalbuminuria

  one year

Study Arms (2)

basal insulin approach

EXPERIMENTAL

Participants will be treated primarily with a daily basal insulin injection ( glargine) with later introduction of prandial coverage with a shortacting insulin.

Drug: basal insulin glargine

standard therapy

ACTIVE COMPARATOR

Participants will continue current mixed insulin management and education

Drug: standard therapy

Interventions

basal insulin glargine DRUG

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.

Also known as: Lantus

basal insulin approach

standard therapy DRUG

Participants will continue with current mixed insulin treatment using NPH , or lente, and regular insulin .

standard therapy

Eligibility Criteria

• Age: 1 Year - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• life expectancy less than three years
• requiring additional diabetes therapy beyond the scope of the trial

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National University, Rwanda: collaborator
• Association Rwandaise des Diabetiques: collaborator

Study Sites (1)

Association Rwandese des Diabetiques

Kigali, Kigali Provence, Rwanda

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine; Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Trevor J Orchard, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 26, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

RW (1)