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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| International Society for Pediatric and Adolescent Diabetes | UNKNOWN |
| Société de Médecine Interne du Burkina Faso | UNKNOWN |
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The goal of this clinical trial is to compare glycemic control and variability between children and adolescents with type 1 diabetes treated by a two daily injection of premixed human insulin (Humulin 30/70) and those who have a basal bolus scheme (Humulin N + Humulin R) in a resources limited setting.
The main question it aims to answer is: what is the effectiveness of premixed human insulin on glycemic control? Ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals. At the end of the initial 16-wk treatment (period 1), all patients will be crossed over to the alternate treatment arm for an additional 16 wk (period 2). Insulin doses will be adjusted weekly by the clinical site according to a prespecified insulin intensification algorithm to achieve target fasting [<110 mg/dl (6.1 mmol/liter)], bedtime [<130 mg/dl (7.2 mmol/liter)], and premeal [<110 mg/dl (6.1 mmol/liter)] glucose levels until HbA1c was below 7.0%.
Subjects will receive training on the FreeStyle Libre CGMS System, electronic hand-held personal digital assistant (e-diary), and self-monitoring of blood glucose (SMBG), including recording glucose, insulin doses, and symptoms of hypo- or hyperglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humulin N plus Humulin R | Active Comparator | 10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals |
|
| Premix human isophane suspension plus insulin human injection | Experimental | 10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| premix insulin human isophane suspension and insulin human | Drug | Sequence (Premix first, then Humulin N + Humulin R): Subjects randomized to this sequence will receive premix insulin, twice per day for 16 weeks. After the first 16 weeks, subjects will cross over to the Humulin N plus Humulin R sequence for a further treatment of 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare improvements from baseline in patient HbA1c when aggressively treated with insulin human isophane plus rapid acting human insulin vs treatment with Premix human insulin | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of hypo events (throughout the trial) | weekly frequency of hypo events and time below range | 8 months |
| Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Souro Sanou | Bobo-Dioulasso | Houet | Burkina Faso | |||
| CHU de Tengandogo |
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| Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso |
| UNKNOWN |
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|
| Humulin N plus Humulin R | Drug | Sequence (Humulin N + Humulin R first, then Premix): Subjects randomized to this sequence will receive basal bolus insulin scheme with Humulin N (twice daily) and Humulin R (before meals) for 16 weeks. After the first 16 weeks, subjects will cross over to the Premix sequence for a further treatment of 16 weeks |
|
The PedsQL 3.2 Diabetes Module is composed of 33 items comprising 5 dimensions for ages 8- 45 years and 32 items for ages 2-7 years. Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problems
| 8 months |
| correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32) | 8 months |
| Ouagadougou |
| Kadiogo |
| Burkina Faso |
| CHU Yalgado Ouedraogo | Ouagadougou | Kadiogo | Burkina Faso |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D000068880 | Isophane Insulin, Human |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007336 | Insulin, Isophane |
| D049528 | Insulin, Long-Acting |
| D061386 | Insulin, Regular, Human |
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