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De klinische studie NCT05076292 voor Type 1 diabetes, Hypoglykemie is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes 22 Lichaamsbeweging Preventie
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De klinische studie NCT05076292 was een interventioneel studie bij Type 1 diabetes, Hypoglykemie en is nu afgerond. Er werd gestreefd naar inclusie van 22 deelnemers vanaf 23 november 2021. De studie werd geleid door Steno Diabetes Center Copenhagen en was gepland te worden voltooid op 8 augustus 2023. Laatste update op ClinicalTrials.gov: 5 december 2023.
Beknopte samenvatting
The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).
The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and...
Toon meerUitgebreide beschrijving
A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.
During the visits and in an outpatient period th...
Toon meerOfficiële titel
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
Aandoeningen
Type 1 diabetesHypoglykemieAndere studie-ID's
- 78618
- 2021-001342-34 (EudraCT-nummer)
NCT-ID
Startdatum (Werkelijk)
2021-11-23
Laatste update geplaatst
2023-12-05
Verwachte einddatum
2023-08-08
Inschrijving (Geschat)
22
Studietype
Interventioneel
FASE
N.v.t.
Status
Afgerond
Trefwoorden
Type 1 Diabetes
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Enkelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Experimenteel150 ug glucagon before exercise 150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise. | GlucaGen 150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise. |
Experimenteel2*75 ug glucagon before exercise and after exercise 75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise. | GlucaGen 150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise. |
Actieve comparatorSaline as placebo Saline as placebo will be administered in the same amount as glucagon before and after exercise. | zoutoplossing Saline will be used as placebo before and after exercise. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Incidence rate of hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Percentage of time below range (PG < 3.9) | From 0-180 minutes post-intervention | |
Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l) | From 0-180 minutes post-intervention | |
Time (min) to hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention | |
Change in plasma glucose levels | From 0-180 minutes post-intervention | |
Incidence rate of hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention | |
Nadir plasma glucose concentration | From 0-180 minutes post-intervention | |
Peak plasma glucose concentration | From 0-180 minutes post-intervention | |
Incremental peak in plasma glucose concentration | From 0-180 minutes post-intervention | |
Mean plasma glucose concentration | From 0-180 minutes post-intervention | |
Plasma glucose Area Under the Curve (AUC) | From 0 to 180 min post-intervention | |
Percentage of time in hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention | |
Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention | From 0-180 minutes post-intervention | |
Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value) | During exercise | |
MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value) | During the three-day outpatient period | |
MARD during the three-hour inpatient study visit (using YSI as reference value) | During exercise | |
Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period | |
Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Age ≥ 18
- T1D ≥ 2 years
- Use of insulin pump or MDI therapy for ≥ 6 months
- Current use of insulin aspart
- HbA1c ≤ 70mmol/mol (8.5%)
- Body mass index (BMI) ≤ 30 kg/m2
- Performs exercise ≥1 time per week
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
- Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
- Known or suspected allergies to glucagon or related products
- History of hypersensitivity or allergic reaction to glucagon or lactose
- Allergy to the patch of the CGM devices
- Patients with pheochromocytoma, insulinoma or gastroparesis
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
- Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Steno Diabetes Center CopenhagenGeen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Sissel Banner Lundemose, Gentofte Municipality, 2820, Denmark