SMASH – A study on simplified carbohydrate estimation using a self-thinking insulin pump in children, adolescents, and young adults with Type 1 Diabetes
Descrizione riassuntiva dello studio
This study investigates people suffering from Type 1 Diabetes. It examines an insulin pump system that partially determines the insulin dosage by itself (a so-called "hybrid Closed Loop System"). For these systems to estimate how much insulin is needed after a meal as accurately as possible, it has so far been required that their users estimate the carbohydrates in meals very precisely. This can be challenging in many situations, especially for children. In this study, we test whether a simplified estimation of the carbohydrate content of each meal (small, medium, large portion) can achieve a similar blood sugar control as an accurate estimation. After an initial visit, during which it is checked whether a person can participate in the study and written consent is obtained, the participating person is trained on the hybrid Closed Loop System. Then, chance decides whether a precise or simplified estimation of carbohydrates is performed before each meal in the following 3 months. The first visit also includes measuring height and weight, the current HbA1c, and a series of questionnaires about life with diabetes. For women of childbearing age who are sexually active, a pregnancy test is conducted. Then the second visit follows. During this, HbA1c, height, and weight are measured again. Additionally, the same questionnaires are filled out again. After that, the method of estimating carbohydrates from meals is changed for the next 3 months. After another 3 months, the third and final visit takes place. Here, HbA1c, height, and weight are measured again, and the questionnaires are filled out. Then, the hybrid Closed Loop System is returned, and the participants return to their usual therapy.
(BASEC)
Intervento studiato
A hybrid Closed Loop System is being studied, which consists of an insulin pump (Ypsonpump from Ypsomed), a glucose sensor (Dexcom G6 from Dexcom), a mobile app (CamAPS FX from CamDia LTD), and a smartphone.
It is examined whether this system, with the simplified estimation of the carbohydrate content of a meal (small, medium, large), achieves the same blood sugar control as when it receives precise estimations of the carbohydrate content of meals.
(BASEC)
Malattie studiate
Type 1 Diabetes
(BASEC)
• Type 1 Diabetes for at least 6 months • Age between 12 and 20 years (inclusive) • Problem-free use of a glucose sensor for at least 5 days in the past (BASEC)
Criteri di esclusione
• Severe visual impairment • Severe hearing impairment • Lack of German language skills (BASEC)
Luogo dello studio
Berna, Zurigo
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Informazioni generali
University hospital of Bern
(ICTRP)
Informazioni scientifiche
University hospital of Bern
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
25.11.2022
(BASEC)
ID di studio ICTRP
NCT05481034 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Simplified Meal Approach Study Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes - a Randomised Controlled Two-centre Crossover Trial (ICTRP)
Titolo pubblico
Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes (ICTRP)
Malattie studiate
Type 1 Diabetes (ICTRP)
Intervento studiato
Device: SMA bolus option;Device: Exactly estimated carbohydrate content bolus option (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: 20 Years
Minimum age: 12 Years
Inclusion Criteria:
- Written informed consent
- Type 1 diabetes as defined by the World Health Organization for at least 6 months
- Age between 12 and 20 years (inclusive)
- Proficient use of continuous glucose monitoring (CGM) or flash glucose monitoring
(FGM) for at least 5 days in the past
- Glycated hemoglobin A1c (HbA1c) =12%
- The participant is willing to wear closed-loop devices
- The participant is willing to follow study specific instructions
- Negative urine-pregnancy test in sexually active female participants of childbearing
potential at screening-visit
Exclusion Criteria:
- Any physical or psychological disease or condition likely to interfere with the normal
conduct of the study and interpretation of the study results
- Known or suspected allergy against insulin
- Participant is pregnant or breast feeding or planning pregnancy within next 6.5 months
- Severe visual impairment
- Severe hearing impairment
- Lack of reliable telephone facility for contact
- Concomitant participation in another trial that interferes with the normal conduct of
the study and interpretation of the study results
- Participant not proficient in German
(ICTRP)
non disponibile
Endpoint primari e secondari
Percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L (ICTRP)
Time spent with sensor glucose values above target (>10.0 mmol/L);Time spent with sensor glucose values >13.9 mmol/L (%);Time spent with sensor glucose measurements < 3.9 mmol/L;Time spent with sensor glucose measurements < 3.0 mmol/L;Time spent with sensor glucose measurements between < 3.9 mmol/L and 7.8 mmol/L (%);Mean sensor glucose level (mmol/L);HbA1c;Mean peak postprandial glucose;Coefficient of sensor glucose variation (%);Standard deviation of sensor glucose variation (mmol/L);Glucose Management Indicator (%);Number of clinically significant hypoglycaemia (number of events with sensor glucose <3.9 mmol/L for at least 15min);Extended hypoglycaemia event rate (number of events with sensor glucose <3.9 mmol/L lasting at least 120min);Extended hyperglycaemia event rate (number of events with sensor glucose >13.9 mmol/L lasting at least 120min);Proportion of participants with sensor glucose in the target range (3.9 - 10.0 mmol/L for >70% of the time. (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Zurich (ICTRP)
Contatti aggiuntivi
Lia Bally, MD PhD, University hospital of Bern (ICTRP)
ID secondari
SMASH (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05481034 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile