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Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections
Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus.
An open-label, treat to target, intervention study in order to compare the metabolic control of once to twice-daily insulin Detemir injections in children and adolescence with type 1 diabetes mellitus.
All eligible patients will be assigned to receive insulin Detemir once daily before breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The starting dose of insulin Detemir will be individually determined.Based on self-measured fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due to hypoglycemic episodes would be switched to treatment consist of twice daily insulin Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration phase, but further up titration is possible and patient does not suffer from hypoglycemic episodes, the titration period would be extended and patient would not be switched to treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient will continue until study end on the maintenance phase.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
An open label,treat to target, prospective, intervention study in order to compare the metabolic control of once to twice-daily insulin detemir injections in children and adolescence with type 1 diabetes mellitus.
Study objectives:
- To assess the efficacy and safety of insulin detemir therapy (once or twice daily) using a treat to target titration protocol for initiating and maintaining therapy in children and adolescents with type 1 diabetes.
- To evaluate the percentage of patients That will achieve a reduction of 0.5% of HbA1c from baseline to end of study evaluation.
- To evaluate Incidence of sever, nocturnal, symptomatic and asymptomatic hypoglycemia and glucose excursions of both hyper and hypoglycemia as measured by the area under the curve determined by the CGMS technique.
Treatment plan:
Patients will be assigned to receive insulin detemir once daily before breakfast. Short acting insulin analog , Novorapid, will be used for mealtime insulin. The starting dose of insulin detemir will be individually determined. Based on self-measured fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at pre breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for subjects aged 13-18 years.
Patients that after 4 weeks titration phase will not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due to hypoglycemic episodes, would be switched to treatment consist of twice daily insulin Detemir.
If the target blood glucose are not achieved at the end of the 4 weeks titration phase, but further up titration is possible and patient does not suffer from hypoglycemic episodes, the titration period would be extended and patient would not be switched to treatment with 2 injections of insulin Detemir.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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-
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Petach-Tikva, Israël
- Schneider Children's Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Informed consent obtained before any trial related activity
- Children with type 1 diabetes who have been treated with insulin for at least 12 months prior to the study.
- Age > 6 years and < 18 years
- HbA1c > 7.7%
- Ability and willingness to accept the study conditions and to inject insulin detemir
Exclusion Criteria:
- Impaired renal function or current renal dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Known hypoglycemia unawareness.
- Known or suspected allergy to trial products.
- Clinical evidence of active liver disease or impaired hepatic function
- Participation in another study (with study drug) within the last 3 months prior to this trial.
- Significant concomitant disease likely to interfere with glucose metabolism
- Proven eating disorders
- Malignancy within the last 5 years
- History of repeated severe hypoglycemia within the last year.
- Known diabetes retinopathy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1
once a day
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Levemir once a day
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Experimenteel: 2
twice a day
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Levemir twice a day
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
HbA1C
Tijdsspanne: at screening visit, at the middle of the study, at the end of the study and prior to sweetching to twice daily treatment
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at screening visit, at the middle of the study, at the end of the study and prior to sweetching to twice daily treatment
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SBGM
Tijdsspanne: 4-8 times a day
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4-8 times a day
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CGMS
Tijdsspanne: 72 hours prior to switching to twice daily treatment and at the end of study
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72 hours prior to switching to twice daily treatment and at the end of study
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Total daily basal and bolus insulin
Tijdsspanne: will be calculated every visit
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will be calculated every visit
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
documentation of hypoglycemic and hyperglycemic episodes
Tijdsspanne: diary will be collected every visit
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diary will be collected every visit
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Moshe Phillip, Professor, Schneider Children Medical Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- rmc004543ctil
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