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A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module
Hedia Diabetes Assistant is a software device intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative Bolus insulin dose.
This study has been designed to investigate the safety and efficacy of a digital insulin bolus calculator with a physical activity module that provides guidance on insulin reduction to patients with type 1 diabetes mellitus prior to and after exercise, based on exercise duration and intensity compared with the patients' habitual diabetes management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Hedia Diabetes Assistant with physical activity module. | Experimental | The participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use the Hedia Diabetes Assistant bolus calculator with the physical activity module (intervention) during a 24-hour period starting one hour before the bout of exercise. |
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| Usual treatment | Active Comparator | The participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use their habitual diabetes management approach during a 24-hour period starting one hour before the bout of exercise (control). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hedia Diabetes Assistant bolus calculator with a physical activity module | Device | Hedia Diabetes Assistant bolus calculator with a physical activity module is a software device that calculates an insulin bolus based on blood glucose, carbohydrates and physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-in-range (blood glucose 3.9-10.0 mmol/l). | 24-hour period starting one hour before exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of no. of hypoglycemic events (blood glucose < 3.9 mmol/l). |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of glycaemic variability (coefficient of variation and standard deviation). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Østerskov | Hedia ApS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Zealand Hospital - Hillerød | Hillerød | 3400 | Denmark |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 24-hour period starting one hour before exercise |
| Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-above-range (>10.0 mmol/l). | 24-hour period starting one hour before exercise |
| Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-below-range (blood glucose < 3.9 mmol/l). | 24-hour period starting one hour before exercise |
| 24-hour period starting one hour before exercise |
| Daily insulin requirement of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the daily intake of insulin in adults with type 1 diabetes mellitus utilising the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to their habitual diabetes management during a 24-hour period starting one hour before exercise. | 24-hour period starting one hour before exercise |
| Daily correctional actions of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the number of daily correctional actions (intake of food or injection of insulin) in adults with type 1 diabetes mellitus utilising the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to their habitual diabetes management during a 24-hour period starting one hour before exercise. | 24-hour period starting one hour before exercise |
| Usability of Hedia Diabetes Assistant bolus calculator with physical activity module | To compare the usability of the physical activity module as part of the Hedia Diabetes Assistant application by System Usability Scale (SUS) in adult patients with type 1 diabetes mellitus. | 1 day |