AzTrials
AzTrials

Type 1 DiabetesSMASHNCT05481034

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

A study testing SMA bolus option and Exactly estimated carbohydrate content bolus option in people with Type 1 Diabetes, run by Lia Bally at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 to 20 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
SMA bolus option and Exactly estimated carbohydrate content bolus option
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesSwitzerland
Study dates
11 Jan 2023to 29 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

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

    Bern, 3010

  • Department of Paediatric Endocrinology and Diabetes, University Children's Hospital Zurich

    Zurich, 8032

Other trials in Switzerland

About this study

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

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).

Read the 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.

Conditions
Type 1 Diabetes
Being tested
SMA bolus option, Exactly estimated carbohydrate content bolus option
Keywords
Type 1 Diabetes, Youth, Adolescents, Artificial pancreas system, Meal announcement
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMA bolus optionDevice

    Also called Simplified meal announcement 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.

  • Exactly estimated carbohydrate content bolus optionDevice

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

Study groups in NCT05481034
Study groupRoleWhat they receive
Simplified carbohydrate estimation first, exact carbohydrate estimation secondExperimentalIn 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.
Receives: Device: SMA bolus option; Device: Exactly estimated carbohydrate content bolus option
Exact carbohydrate estimation first, simplified carbohydrate estimation second.ExperimentalIn 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.
Receives: Device: SMA bolus option; Device: Exactly estimated carbohydrate content bolus option

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (15)

  1. 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)

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

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

    Percentage of time spent with sensor glucose values >13.9 mmol/L (%)

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

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

    The percentage of time with sensor glucose measurements < 3.9 mmol/L (%)

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

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

    The percentage of time with sensor glucose measurements < 3.0 mmol/L (%)

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

  5. 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 (%)

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

  6. Mean sensor glucose level (mmol/L)

    Mean of all sensor glucose levels (mmol/L)

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

  7. HbA1c

    Glycated hemoglobin A1c (%)

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

  8. 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).

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

  9. Coefficient of sensor glucose variation (%)

    Coefficient of sensor glucose variation (%)

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

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

    Standard deviation of sensor glucose variation (mmol/L)

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

  11. Glucose Management Indicator (%)

    Glucose Management Indicator (%)

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

  12. 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

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

  13. 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

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

  14. 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

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

  15. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start11 Jan 2023
  3. Primary completion29 Sep 2023
  4. Study completion29 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481034
Sponsor's protocol ID
SMASH
Acronym
SMASH
Status last verified
Oct 2023
First submitted
28 Jul 2022
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39560745

Questions about this trial

What is this clinical trial studying?

A study testing SMA bolus option and Exactly estimated carbohydrate content bolus option in people with Type 1 Diabetes, run by Lia Bally at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05481034, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in