SMASH: Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 type 1 diabetes. 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 type 1 diabetes, 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 type 1 diabetes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
Other Names:
Device: Exactly estimated carbohydrate content bolus option
The carbohydrate content of meals is estimated in grams of carbohydrates prior to a meal bolus
|
| Experimental: 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. |
Device: 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.
Other Names:
Device: Exactly estimated carbohydrate content bolus option
The carbohydrate content of meals is estimated in grams of carbohydrates prior to a meal bolus
|
Outcome Measures
Primary Outcome Measures
- Percentage of sensor glucose measurements between 3.9 and 10.0 mmol/L [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
The percentage of sensor glucose measurements between 3.9 and 10.0 mmol/L will be compared between both intervention arms
Secondary Outcome Measures
- Sensor glucose measurements >10.0 mmol/L [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
The percentage of sensor glucose measurements >10.0 mmol/L
- Sensor glucose measurements < 3.9 mmol/L [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
The percentage of sensor glucose measurements < 3.9 mmol/L
- Sensor glucose measurements < 3.0 mmol/L [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
The percentage of sensor glucose measurements < 3.0 mmol/L
- Sensor glucose measurements > 20.0 mmol/L [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
The percentage of sensor glucose measurements > 20.0 mmol/L
- Mean sensor glucose measurements [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
Mean of all sensor glucose measurements
- Glycated hemoglobin A1c [Measured before and after 3 months of the experimental period and before and after 3 months of the control period]
Glycated hemoglobin A1c measured before and after each study period
- Total daily insulin dose [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
Mean total daily insulin dose infused
- Total daily basal insulin dose [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
Mean total daily basal insulin dose infused
- Total daily bolus insulin dose [24 hours per day during the 3 months of the experimental period and 3 months of the control period]
Mean total daily bolus insulin dose infused
Other Outcome Measures
- Diabetes Distress simplified meal announcement [At baseline and at the end of the 3 months experimental period]
Measurement of distress associated with the use of closed-loop insulin delivery using simplified meal announcements via the Diabetes Distress questionnaire
- Diabetes Distress estimated carbohydrate content calculation [At baseline and at the end of the 3 months control period]
Measurement of distress associated with the use of closed-loop insulin delivery using estimated carbohydrate content calculations via the Diabetes Distress questionnaire
- Problem areas in the treatment of diabetes simplified meal announcements [At baseline and at the end of the 3 months experimental period]
Measurement of problems associated with the use of closed-loop insulin delivery using simplified meal announcements via the Problem Areas In the treatment of Diabetes questionnaire
- Problem areas in the treatment of diabetes carbohydrate content calculation [At baseline and at the end of the 3 months control period]
Measurement of problems associated with the use of closed-loop insulin delivery using carbohydrate content calculation via the Problem Areas In the treatment of Diabetes questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent
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Type 1 diabetes as defined by the World Health Organization for at least 6 months
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Age between 12 and 20 years (inclusive)
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Use of continuous glucose monitoring (CGM) for ≥ 3 months
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Glycated hemoglobin A1c (HbA1c) ≤12%
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The participant is willing to wear closed-loop devices
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The participant is willing to follow study specific instructions
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Female participants of child bearing age should using effective contraception and must have a negative urine- humane Choriongonadotropin (HCG) pregnancy test at screening
Exclusion Criteria:
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Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
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Known or suspected allergy against insulin
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Participant is pregnant or breast feeding or planning pregnancy within next 12 months
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Severe visual impairment
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Severe hearing impairment
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Lack of reliable telephone facility for contact
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Concomitant participation in another trial that interferes with the normal conduct of the study and interpretation of the study results
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Participant not proficient in German
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
- University of Zurich
Investigators
- Principal Investigator: Lia Bally, MD PhD, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMASH