Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control
Klíčová slova
Abstraktní
Termíny
| Poslední ověření: | 05/31/2020 |
| První předloženo: | 06/19/2019 |
| Odhadovaná registrace vložena: | 06/20/2019 |
| První zveřejnění: | 06/23/2019 |
| Poslední aktualizace byla odeslána: | 06/07/2020 |
| Poslední aktualizace zveřejněna: | 06/10/2020 |
| Aktuální datum zahájení studie: | 06/30/2019 |
| Odhadované datum dokončení primární: | 08/08/2019 |
| Odhadované datum dokončení studie: | 12/29/2019 |
Stav nebo nemoc
Intervence / léčba
Other: Physical activity
Other: FreeStyle Libre
Other: SenseWear Armband
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Active Comparator: Individualized carbohydrate intake Based on glucose sensor level, carbohydrate (orange juice, Oasis classic) will then be given as follow:
If sensor glucose level is under < 4.5 mmol/L, the camp staff will treat hypoglycemia according to the camp procedure, If sensor glucose level is between 4.5 and 7.0 mol/L, 0.5g of CHO/kg body weight will be given, If sensor glucose level is between 7.1 and 10.0 mmol/L, 0.25g of CHO/kg body weight will be given, If sensor glucose level is between 10.1 and 15.0 mmol/L, no CHO will be given, If sensor glucose level is > 15.1 mmol/L, the camp staff will treat hyperglycemia according to the camp procedure. | |
| Active Comparator: Usual camp protocol As per camp routine care, there will be no mandatory glucose level measurement before the start of physical activity if no symptoms of hypoglycemia or hyperglycemia appear. |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 7 Years Na 7 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | Inclusion Criteria: 1. Males or females between the 7 and 16 years of old. 2. Clinical diagnosis of type 1 diabetes for at least 6 months. 3. Using continuous subcutaneous insulin infusion therapy or multiple daily injections. 4. HbA1c ≤ 12.0%. 5. Practicing team sports (soccer, basketball, hockey, tennis) at the summer camp. Exclusion Criteria: 1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 2. Severe hypoglycemic episode within two weeks of inclusion in the study. 3. Using the Medtronic 670G Insulin Pump as a treatment Mode 4. Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable. 5. Acute disease in the last 3 months that would affect ability to do physical activity. 6. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation). |
Výsledek
Primární výsledná opatření
1. Percentage of time of interstitial glucose concentrations spent between 4.0-10.0 mmol/L [60 minutes]
Měření sekundárních výsledků
1. Change in glucose concentrations [60 minutes]
2. Mean time (minutes) to the first hypoglycemic event [60 minutes]
3. Mean interstitial glucose concentration [60 minutes]
4. Standard deviation of glucose concentration [60 minutes]
5. Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L [120 minutes]
6. Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L [120 minutes]
7. Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L [120 minutes]
8. Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L [120 minutes]
9. Total number of confirmed hypoglycemia episodes requiring treatment [120 minutes]
