Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Youth, Adolescents, Artificial pancreas system, Meal announcement
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.
Interventions
DEVICESMA bolus option
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.
DEVICEExactly estimated carbohydrate content bolus option
The carbohydrate content of meals is estimated in grams of carbohydrates prior to a meal bolus
Sponsors
University of Zurich
Lia Bally
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 (%) |
| 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). |
| 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 (%) |
| 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 |
| 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 |
| 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. |
| 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) |
| 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 (%) |
| 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 (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time of closed-loop operation including engagement with specific functionalities | From the first day of the respective study period to 3 months thereafter | Utility evaluation |
| Diabetes Distress Scale | At the predefined study visit 3 months after the start of the respective period. | Measurement of distress associated with the use of closed-loop insulin delivery using the Diabetes Distress questionnaire |
| Hypoglycaemia confidence scale | At the predefined study visit 3 months after the start of the respective period. | 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 |
| Psychosocial factors important to quality of life | At the predefined study visit 3 months after the start of the respective period. | These factors include anxiety, stress, depressions, etc. |
| Food Frequency Questionnaire to assess dietary intake habits | At the predefined study visit 3 months after the start of the respective period. | Dietary intake (quantity and quality) |
| Number of severe hypoglycaemia events | From the first day of the respective study period to 3 months thereafter | Hypoglycaemia requiring third-party assistance to administer carbohydrates or other resuscitative action |
| Diabetic ketoacidosis | From the first day of the respective study period to 3 months thereafter | ADA definition |
| Significant ketonaemia | From the first day of the respective study period to 3 months thereafter | Value \> 3.0 mmol/L |
| Nature and severity of adverse events | From the first day of the respective study period to 3 months thereafter | AE including SADE and SAE |
| Total daily basal insulin dose | From the first day of the respective study period to 3 months thereafter | Mean total daily basal insulin dose infused |
| Total daily bolus insulin dose | From the first day of the respective study period to 3 months thereafter | Mean total daily bolus insulin dose infused |
Countries
Switzerland
Outcome results
None listed