Supporting Meal Management in Type 1 Diabetes (SUMMIT1)
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ClinicalTrials.gov Identifier: NCT05671679 |
Recruitment Status :
Not yet recruiting
First Posted : January 5, 2023
Last Update Posted : January 5, 2023
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Sponsor:
Lia Bally
Information provided by (Responsible Party):
Lia Bally, University Hospital Inselspital, Berne
Brief Summary:
Carbohydrate count marks the cornerstone of Type 1 Diabetes management. Eventhough it is a crucial task, it is burdensome and prone to error. Therefore, we want to explore the effect that SNAQ, a food analyser app would have in glycaemic control by facilitating the task of carbohydrate estimation.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Other: SNAQ app Other: Traditional carbohydrate counting | Not Applicable |
Show detailed description
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The study will follow a randomized two-arm parallel design. Study visits will be done remotely via video calls or in-clinic when coinciding with usual care appointments. Following a baseline visit and before randomization, baseline characteristics and medical history of the participants will be collected (as detailed in section 4.3). Following randomization, the intervention group will use SNAQ app for the first 3 weeks while the control group will proceed without any modification/intervention by the study team. After the first 3 weeks, the control group will undergo 3 weeks of SNAQ app use (weeks 4-6). At the end of their respective SNAQ app periods (weeks 4-6 for the intervention group and weeks 7-9 for the control group), both groups will discontinue the use of SNAQ app for 3 weeks to assess sustainability of potential effects. Finally, both groups will be offered to use SNAQ app for 3 additional weeks as per their preference (follow-up period). |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Supporting Meal Management in Type 1 Diabetes |
Estimated Study Start Date : | March 2023 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | September 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
Arm | Intervention/treatment |
---|---|
Experimental: Intervention
The intervention group will use SNAQ app for the first 3 weeks (baseline to V1) of the study.
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Other: SNAQ app
SNAQ is a smartphone food analysis app that estimates the macronutrient content of a meal, based on a single image. The app first determines meal content in terms of food components with input from the user to correct or add further components (e.g. foods, ingredients, sauces, herbs or seasonings). Then, the total macronutrient and energy content of the meal is determined based on the estimated volume and information from a nutritional database. Of note, the application also allows for assessing nutritional content of packaged foods by means of a barcode scanning function. The user can always adapt proposed nutritional contents at their own discretion. Meal macronutrients alongside the food pictures are collected in a detailed log which allows users to review their dietary choices. The product is not conceived by its manufacturer to be used for medical purposes and can thus not be considered a medical device. |
Active Comparator: Control
The control group will continue estimating the carbohydrate count using their traditional methods for the first three weeks of the study (baseline to V1).
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Other: Traditional carbohydrate counting
Patients will follow their tratitional methods of carbohydrate counting during the control period. In addition to assess sutainability of the intervention, following the control period, the control group will also go an intervention period of 3 weeks using the SNAQ App. |
Primary Outcome Measures :
- Percentage of time with sensor glucose in the target range [ Time Frame: 3-week intervention period (Day 1 to Day 21) ]Percentage of time with sensor glucose in the target range between 3.9 to 10.0mmol/L, %
Secondary Outcome Measures :
- Percentage of time with sensor glucose in hyperglycaemia [ Time Frame: 3-week intervention period (Day 1 to Day 21) ]Percentage of time with sensor glucose in the target range above 10.0mmol/L, %
- Percentage of time with sensor glucose in hypoglycaemia [ Time Frame: 3-week intervention period (Day 1 to Day 21) ]Percentage of time with sensor glucose in the target range below 3.9 mmol/L, %
- Percentage of postprandial time with sensor glucose in target range [ Time Frame: 3-week intervention period (Day 1 to Day 21) ]Percentage of postprandial time with sensor glucose in target range between 3.9 to 10.0 mmol/L
- Percentage of postprandial time with sensor glucose in hyperglycaemia [ Time Frame: 3-week intervention period (Day 1 to Day 21) ]Percentage of postprandial time with sensor glucose in the target range above 10.0mmol/L, %
- Percentage of postprandial time with sensor glucose in hypoglycaemia [ Time Frame: 3-week intervention period (Day 1 to Day 21) ]Percentage of postprandial time with sensor glucose in the target range below 3.9 mmol/L, %
Information from the National Library of Medicine
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Ages Eligible for Study: | 12 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent
- Adults (aged 18 years or older)
- Type 1 diabetes (as defined by World Health Organization-WHO for at least 12 month)
- Current use of a commercial hybrid closed-loop system
- HbA1c≤12% (measured within the past 3 months)
- Willing to use the SNAQ app on a daily basis for over 3 weeks
- The participant is willing to follow study specific instructions and share their treatment data with the study team
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
- Previous use of SNAQ app for more than 5 days within the past 3 months
- Self-reported pregnancy, planed pregnancy within next 3 months or breast-feeding
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05671679
Contacts
Contact: Lia Bally, MD PhD | +41 31 63 2 36 77 | lia.bally@insel.ch | |
Contact: David Herzig, PhD | +41 31 66 4 29 47 | david.herzig@extern.insel.ch |
Sponsors and Collaborators
Lia Bally
Investigators
Principal Investigator: | Lia Bally, MD PhD | UDEM Inselspital, University Hospital of Berne, and University Berne |
Responsible Party: | Lia Bally, MD PhD, University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT05671679 |
Other Study ID Numbers: |
SUMMIT1 |
First Posted: | January 5, 2023 Key Record Dates |
Last Update Posted: | January 5, 2023 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | After publication of the study results in a peer-reviewed journal. |
Access Criteria: | Contact with an approval by the corresponding author. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Lia Bally, University Hospital Inselspital, Berne:
Carbohydrates Continuous glucose measurement Closed-loop systems |
Type 1 Diabetes Hyperglycaemia Hypoglycaemia |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |