Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Device: SMA bolus optionDevice: Exactly estimated carbohydrate content bolus option
- Registration Number
- NCT05481034
- Lead Sponsor
- Lia Bally
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Simplified carbohydrate estimation first, exact carbohydrate estimation second SMA bolus option 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. Simplified carbohydrate estimation first, exact carbohydrate estimation second Exactly estimated carbohydrate content bolus option 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. Exact carbohydrate estimation first, simplified carbohydrate estimation second. SMA bolus option 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. Exact carbohydrate estimation first, simplified carbohydrate estimation second. Exactly estimated carbohydrate content bolus option 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.
- Primary Outcome Measures
Name Time Method Percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L From the first day of the respective study period to 3 months thereafter 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.
- Secondary Outcome Measures
Name Time Method Time spent with sensor glucose measurements < 3.9 mmol/L From the first day of the respective study period to 3 months thereafter The percentage of time with sensor glucose measurements \< 3.9 mmol/L (%)
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 Percentage of time spent with sensor glucose values above target (\>10.0 mmol/L)
Mean peak postprandial glucose From the first day of the respective study period to 3 months thereafter 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).
Number of clinically significant hypoglycaemia (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 Number of events with sensor glucose \<3.9 mmol/L for at least 15min
Time spent with sensor glucose values >13.9 mmol/L (%) From the first day of the respective study period to 3 months thereafter Percentage of time spent with sensor glucose values \>13.9 mmol/L (%)
Extended hypoglycaemia event rate (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 Number of events with sensor glucose \<3.9 mmol/L lasting at least 120min
Time spent with sensor glucose measurements < 3.0 mmol/L From the first day of the respective study period to 3 months thereafter The percentage of time with sensor glucose measurements \< 3.0 mmol/L (%)
Time spent with sensor glucose measurements between < 3.9 mmol/L and 7.8 mmol/L (%) From the first day of the respective study period to 3 months thereafter The percentage of time with sensor glucose between \< 3.9 mmol/L and 7.8 mmol/L (%)
Mean sensor glucose level (mmol/L) From the first day of the respective study period to 3 months thereafter Mean of all sensor glucose levels (mmol/L)
HbA1c At baseline and at the predefined study visits (3 months after the start of the respective periods) Glycated hemoglobin A1c (%)
Coefficient of sensor glucose variation (%) From the first day of the respective study period to 3 months thereafter Coefficient of sensor glucose variation (%)
Standard deviation of sensor glucose variation (mmol/L) From the first day of the respective study period to 3 months thereafter Standard deviation of sensor glucose variation (mmol/L)
Glucose Management Indicator (%) From the first day of the respective study period to 3 months thereafter Glucose Management Indicator (%)
Extended hyperglycaemia event rate (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 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. 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.
Trial Locations
- Locations (2)
Department of Paediatric Endocrinology and Diabetes, University Children's Hospital Zurich
🇨🇭Zürich, Switzerland
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
🇨🇭Bern, Switzerland