Clinical trial NCT05481034: Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Youth
Adolescents
Artificial pancreas system
Meal announcement
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2022-07-29
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L
timeFrame: From the first day of the respective study period to 3 months thereafter
Secondary outcomes:
measure: Time spent with sensor glucose values above target (>10.0 mmol/L)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Time spent with sensor glucose values >13.9 mmol/L (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Time spent with sensor glucose measurements < 3.9 mmol/L
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Time spent with sensor glucose measurements < 3.0 mmol/L
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Time spent with sensor glucose measurements between < 3.9 mmol/L and 7.8 mmol/L (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Mean sensor glucose level (mmol/L)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: HbA1c
timeFrame: At baseline and at the predefined study visits (3 months after the start of the respective periods)
measure: Mean peak postprandial glucose
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Coefficient of sensor glucose variation (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Standard deviation of sensor glucose variation (mmol/L)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Glucose Management Indicator (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Number of clinically significant hypoglycaemia (number of events with sensor glucose <3.9 mmol/L for at least 15min)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Extended hypoglycaemia event rate (number of events with sensor glucose <3.9 mmol/L lasting at least 120min)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Extended hyperglycaemia event rate (number of events with sensor glucose >13.9 mmol/L lasting at least 120min)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Proportion of participants with sensor glucose in the target range (3.9 - 10.0 mmol/L for >70% of the time.
timeFrame: From the first day of the respective study period to 3 months thereafter
Other outcomes:
measure: Total daily basal insulin dose
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Total daily bolus insulin dose
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Percentage of time of closed-loop operation including engagement with specific functionalities
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Diabetes Distress Scale
timeFrame: At the predefined study visit 3 months after the start of the respective period.
measure: Hypoglycaemia confidence scale
timeFrame: At the predefined study visit 3 months after the start of the respective period.
measure: Psychosocial factors important to quality of life
timeFrame: At the predefined study visit 3 months after the start of the respective period.
measure: Food Frequency Questionnaire to assess dietary intake habits
timeFrame: At the predefined study visit 3 months after the start of the respective period.
measure: Number of severe hypoglycaemia events
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Diabetic ketoacidosis
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Significant ketonaemia
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Nature and severity of adverse events
timeFrame: From the first day of the respective study period to 3 months thereafter
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
city: Zürich
country: Switzerland
facility: Department of Paediatric Endocrinology and Diabetes, University Children's Hospital Zurich
Study officials:
affiliation: University hospital of Bern
name: Lia Bally, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: