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

NCT ID: NCT05481034

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2023-09-29

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simplified carbohydrate estimation first, exact carbohydrate estimation second

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.

Group Type: EXPERIMENTAL

SMA bolus option

Intervention Type: 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.

Exactly estimated carbohydrate content bolus option

Intervention Type: DEVICE

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

Exact carbohydrate estimation first, simplified carbohydrate estimation second.

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.

Group Type: EXPERIMENTAL

SMA bolus option

Intervention Type: 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.

Exactly estimated carbohydrate content bolus option

Intervention Type: DEVICE

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

Interventions

SMA 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.

Intervention Type: DEVICE

Exactly estimated carbohydrate content bolus option

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

Intervention Type: DEVICE

Other Intervention Names

Simplified meal announcement bolus option

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Lia Bally

OTHER

Sponsor Role: lead

Responsible Party

Lia Bally

Prof. Dr.med. et Dr. phil.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lia Bally, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University hospital of Bern

Locations

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

Bern, , Switzerland

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

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 39560745 (View on PubMed)

Other Identifiers

SMASH

Identifier Type: -

Identifier Source: org_study_id