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The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone gastric bypass surgery. The main question it aims to answer is:
• Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after gastric bypass surgery?
Researchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous glucose monitor | Experimental | The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week. After the screening week, the patients will be given dietary guidance on how to avoid hypoglycaemia and be given a capillary glucometer (standard treatment procedure). The patients will also use a continuous glucose monitor and receiver which displays real-time glucose levels, for 6 weeks, to learn how to avoid hypoglycaemia. |
|
| No continuous glucose monitor | No Intervention | The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week. After the screening week, the patients will be given dietary guidance on how to avoid hypoglycaemia and be given a capillary glucometer (standard treatment procedure). The patients will not use a continuous glucose monitor during the following 5 weeks, but during week 6 the patient will wear a blinded continuous glucose monitor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitor (Dexcom® G7) | Device | Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.0 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor. | Interstitial glucose is measured for one week during the screening week and for one week during week 6. | Screening (week 0) and week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor. | Interstitial glucose is measured for one week during the screening week and one week during week 6. | Screening (week 0) and week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi Borgeraas, PhD | Contact | 004746707000 | heibor@siv.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust | Recruiting | Tønsberg | Vestfold | 3103 | Norway |
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| • Difference between the two treatment arms in change in weekly time (total and nocturnal) spent with hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor. | Interstitial glucose is measured for one week during the screening week and one week during week 6. | Screening (week 0) and week 6 |
| • Difference between the two treatment arms in change in weekly events (diurnal, total and nocturnal) of hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the sceening week to week 6, measured with a continuous glucose monitor. | Interstitial glucose is measured for one week during the screening week and one week during week 6. | Screening (week 0) and week 6 |