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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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The purpose of the study is to examine whether a simplified meal approach (as compared to exact carbohydrate counting) can alleviate the need of carbohydrate counting without worsening postprandial control in youth and young adults with type 1 diabetes using hybrid closed-loop insulin delivery with the Cambridge Artificial Pancreas FX System (CamAPS FX system).
Optimal glycaemic control is the aim of diabetes care and critical in the prevention of diabetes-related complications. Despite advances in diabetes technologies and medications, many current youth and young adults (YYA) with type 1 diabetes (T1D) are not meeting desired glycaemic targets, representing a missed opportunity for improving lifetime outcomes.
A variety of factors including peer group influences, importance of body image, less parental oversight, greater risk-taking, and performance pressure challenge daily self-management in YYA with T1D. Disengagement from care and barriers for optimal glycaemic management in YYA have been mainly shown to be substantially influenced by perceived burden of daily tasks.
Although the recently introduced closed-loop systems, which link insulin delivery to sensor glucose levels, offer promising opportunities to improve glucose control in YYA with T1D, they still require the user to estimate carbohydrates. The perceived burden of exact carbohydrate counting (ECC), the limited evidence supporting its glycaemic benefit and corrective potential of algorithm-driven background insulin titration question its necessity during hybrid-closed loop insulin treatment. Instead, a simplified meal approach (SMA), which only requires the user to select the meal carbohydrate category (small/medium/large), has the potential to alleviate the burden of ECC during hybrid closed-loop insulin therapy whilst resulting in similar glycaemic benefits.
The investigators therefore hypothesize that a simplified meal approach (SMA) using the CamAPS FX system would achieve comparable glucose control compared with the use of the CamAPS FX system with ECC in YYA with T1D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simplified carbohydrate estimation first, exact carbohydrate estimation second | Experimental | In the first study period, participants will use the CamAPS FX system and adopt the "simplified meal announcement" (SMA) option to bolus for their meals. SMA comprises the selection of predefined carbohydrate quantities for meal insulin dosing. Meal carbohydrate contents will be set on an individual basis at the baseline visit. In the second study period, Participants will use the CamAPS FX system and insert the estimated grams of carbohydrates into the application as exactly as possible in order to bolus for their meals. |
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| Exact carbohydrate estimation first, simplified carbohydrate estimation second. | Experimental | In the first study period, participants will use the CamAPS FX system and insert the estimated grams of carbohydrates into the application as exactly as possible in order to bolus for their meals. In the second study period, participants will use the CamAPS FX system and adopt the "simplified meal announcement" (SMA) option to bolus for their meals. SMA comprises the selection of predefined carbohydrate quantities for meal insulin dosing. Meal carbohydrate contents will be set on an individual basis at the baseline visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMA bolus option | Device | SMA comprises the selection of predefined carbohydrate quantities for meal insulin dosing. Meal carbohydrate contents will be set on an individual basis at the baseline visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L | The percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L will be compared between both intervention arms. Primary analysis will be carried out according to a non-inferiority framework. | From the first day of the respective study period to 3 months thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent with sensor glucose values above target (>10.0 mmol/L) | Percentage of time spent with sensor glucose values above target (>10.0 mmol/L) | From the first day of the respective study period to 3 months thereafter |
| Time spent with sensor glucose values >13.9 mmol/L (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Total daily basal insulin dose | Mean total daily basal insulin dose infused | From the first day of the respective study period to 3 months thereafter |
| Total daily bolus insulin dose | Mean total daily bolus insulin dose infused |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lia Bally, MD PhD | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39560745 | Derived | Laesser CI, Piazza C, Schorno N, Nick F, Kastrati L, Zueger T, Barnard-Kelly K, Wilinska ME, Nakas CT, Hovorka R, Herzig D, Konrad D, Bally L. Simplified meal announcement study (SMASH) using hybrid closed-loop insulin delivery in youth and young adults with type 1 diabetes: a randomised controlled two-centre crossover trial. Diabetologia. 2025 Feb;68(2):295-307. doi: 10.1007/s00125-024-06319-w. Epub 2024 Nov 19. |
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Anonymised individual participant data will be shared after inquiry via a validated sharing platform (yet to be defined). Anonymised data packages will be available once the final study results are published in a peer-reviewed journal.
After publication of the study results in a peer-reviewed journal.
Contact with and approval by the corresponding author
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Exactly estimated carbohydrate content bolus option | Device | The carbohydrate content of meals is estimated in grams of carbohydrates prior to a meal bolus |
|
Percentage of time spent with sensor glucose values >13.9 mmol/L (%) |
| From the first day of the respective study period to 3 months thereafter |
| Time spent with sensor glucose measurements < 3.9 mmol/L | The percentage of time with sensor glucose measurements < 3.9 mmol/L (%) | From the first day of the respective study period to 3 months thereafter |
| Time spent with sensor glucose measurements < 3.0 mmol/L | The percentage of time with sensor glucose measurements < 3.0 mmol/L (%) | From the first day of the respective study period to 3 months thereafter |
| Time spent with sensor glucose measurements between < 3.9 mmol/L and 7.8 mmol/L (%) | The percentage of time with sensor glucose between < 3.9 mmol/L and 7.8 mmol/L (%) | From the first day of the respective study period to 3 months thereafter |
| Mean sensor glucose level (mmol/L) | Mean of all sensor glucose levels (mmol/L) | From the first day of the respective study period to 3 months thereafter |
| HbA1c | Glycated hemoglobin A1c (%) | At baseline and at the predefined study visits (3 months after the start of the respective periods) |
| Mean peak postprandial glucose | Mean peak postprandial glucose (mmol/L) assessed within 180min following main meals (defined as carbohydrate amounts >25g entered into the CamAPS app by the participants). | From the first day of the respective study period to 3 months thereafter |
| Coefficient of sensor glucose variation (%) | Coefficient of sensor glucose variation (%) | From the first day of the respective study period to 3 months thereafter |
| Standard deviation of sensor glucose variation (mmol/L) | Standard deviation of sensor glucose variation (mmol/L) | From the first day of the respective study period to 3 months thereafter |
| Glucose Management Indicator (%) | Glucose Management Indicator (%) | From the first day of the respective study period to 3 months thereafter |
| Number of clinically significant hypoglycaemia (number of events with sensor glucose <3.9 mmol/L for at least 15min) | Number of events with sensor glucose <3.9 mmol/L for at least 15min | From the first day of the respective study period to 3 months thereafter |
| Extended hypoglycaemia event rate (number of events with sensor glucose <3.9 mmol/L lasting at least 120min) | Number of events with sensor glucose <3.9 mmol/L lasting at least 120min | From the first day of the respective study period to 3 months thereafter |
| Extended hyperglycaemia event rate (number of events with sensor glucose >13.9 mmol/L lasting at least 120min) | Number of events with sensor glucose >13.9 mmol/L lasting at least 120min | From the first day of the respective study period to 3 months thereafter |
| Proportion of participants with sensor glucose in the target range (3.9 - 10.0 mmol/L for >70% of the time. | Proportion of participants with sensor glucose in the target range (3.9 - 10.0 mmol/L for >70% of the time. | From the first day of the respective study period to 3 months thereafter |
| From the first day of the respective study period to 3 months thereafter |
| Percentage of time of closed-loop operation including engagement with specific functionalities | Utility evaluation | From the first day of the respective study period to 3 months thereafter |
| Diabetes Distress Scale | Measurement of distress associated with the use of closed-loop insulin delivery using the Diabetes Distress questionnaire | At the predefined study visit 3 months after the start of the respective period. |
| Hypoglycaemia confidence scale | HCS is a 9-item self-report scale that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems | At the predefined study visit 3 months after the start of the respective period. |
| Psychosocial factors important to quality of life | These factors include anxiety, stress, depressions, etc. | At the predefined study visit 3 months after the start of the respective period. |
| Food Frequency Questionnaire to assess dietary intake habits | Dietary intake (quantity and quality) | At the predefined study visit 3 months after the start of the respective period. |
| Number of severe hypoglycaemia events | Hypoglycaemia requiring third-party assistance to administer carbohydrates or other resuscitative action | From the first day of the respective study period to 3 months thereafter |
| Diabetic ketoacidosis | ADA definition | From the first day of the respective study period to 3 months thereafter |
| Significant ketonaemia | Value > 3.0 mmol/L | From the first day of the respective study period to 3 months thereafter |
| Nature and severity of adverse events | AE including SADE and SAE | From the first day of the respective study period to 3 months thereafter |
| Department of Paediatric Endocrinology and Diabetes, University Children's Hospital Zurich | Zurich | 8032 | Switzerland |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |