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Completed

NCT Number: NCT05481034

Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes

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).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland, Bern, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Simplified meal announcement bolus option

Exactly estimated carbohydrate content bolus option

Device

The carbohydrate content of meals is estimated in grams of carbohydrates prior to a meal bolus

Primary outcomes

  1. Percentage of time with sensor glucose measurements between 3.9 and 10.0 mmol/L

    Time frame: 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 outcomes

  1. Time spent with sensor glucose values above target (>10.0 mmol/L)

    Time frame: 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)

  2. Time spent with sensor glucose values >13.9 mmol/L (%)

    Time frame: 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 (%)

  3. Time spent with sensor glucose measurements < 3.9 mmol/L

    Time frame: 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 (%)

  4. Time spent with sensor glucose measurements < 3.0 mmol/L

    Time frame: 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 (%)

  5. Time spent with sensor glucose measurements between < 3.9 mmol/L and 7.8 mmol/L (%)

    Time frame: 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 (%)

  6. Mean sensor glucose level (mmol/L)

    Time frame: From the first day of the respective study period to 3 months thereafter

    Mean of all sensor glucose levels (mmol/L)

  7. HbA1c

    Time frame: At baseline and at the predefined study visits (3 months after the start of the respective periods)

    Glycated hemoglobin A1c (%)

  8. Mean peak postprandial glucose

    Time frame: 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).

  9. Coefficient of sensor glucose variation (%)

    Time frame: From the first day of the respective study period to 3 months thereafter

    Coefficient of sensor glucose variation (%)

  10. Standard deviation of sensor glucose variation (mmol/L)

    Time frame: From the first day of the respective study period to 3 months thereafter

    Standard deviation of sensor glucose variation (mmol/L)

  11. Glucose Management Indicator (%)

    Time frame: From the first day of the respective study period to 3 months thereafter

    Glucose Management Indicator (%)

  12. Number of clinically significant hypoglycaemia (number of events with sensor glucose <3.9 mmol/L for at least 15min)

    Time frame: 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

  13. Extended hypoglycaemia event rate (number of events with sensor glucose <3.9 mmol/L lasting at least 120min)

    Time frame: 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

  14. Extended hyperglycaemia event rate (number of events with sensor glucose >13.9 mmol/L lasting at least 120min)

    Time frame: 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

  15. Proportion of participants with sensor glucose in the target range (3.9 - 10.0 mmol/L for >70% of the time.

    Time frame: 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.

Other outcomes

  1. Total daily basal insulin dose

    Time frame: From the first day of the respective study period to 3 months thereafter

    Mean total daily basal insulin dose infused

  2. Total daily bolus insulin dose

    Time frame: From the first day of the respective study period to 3 months thereafter

    Mean total daily bolus insulin dose infused

  3. Percentage of time of closed-loop operation including engagement with specific functionalities

    Time frame: From the first day of the respective study period to 3 months thereafter

    Utility evaluation

  4. Diabetes Distress Scale

    Time frame: 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

  5. Hypoglycaemia confidence scale

    Time frame: 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

  6. Psychosocial factors important to quality of life

    Time frame: At the predefined study visit 3 months after the start of the respective period.

    These factors include anxiety, stress, depressions, etc.

  7. Food Frequency Questionnaire to assess dietary intake habits

    Time frame: At the predefined study visit 3 months after the start of the respective period.

    Dietary intake (quantity and quality)

  8. Number of severe hypoglycaemia events

    Time frame: 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

  9. Diabetic ketoacidosis

    Time frame: From the first day of the respective study period to 3 months thereafter

    ADA definition

  10. Significant ketonaemia

    Time frame: From the first day of the respective study period to 3 months thereafter

    Value > 3.0 mmol/L

  11. Nature and severity of adverse events

    Time frame: From the first day of the respective study period to 3 months thereafter

    AE including SADE and SAE

Sponsors and collaborators

Lead sponsor

Lia Bally

Other

Collaborators

  • University of Zurich

Registry information

Official study 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

Acronym: SMASH

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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