Hypoglycemia Non-DiabeticHypoSurgeNCT06468865
Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery
A study testing Continuous glucose monitor (Dexcom® G7) in people with Hypoglycemia Non-Diabetic and Gastric Bypass Surgery, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia Non-Diabetic, Gastric Bypass Surgery
- What is being tested?
- Continuous glucose monitor (Dexcom® G7)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 12 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gastric bypass surgery at least 1 year ago
- Age ≥18 years
- Symptomatic postprandial hypoglycaemia; capillary glucose level <3.0 mmol/L 1-4 hours after meals
Who cannot join
- Not able to give informed consent
- Reduced compliance due to severe mental and psychiatric conditions
- Use of insulin or sulfonylureas
- Use of systemic corticosteroids
- Primary or secondary adrenal insufficiency
- Insulinoma
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- Severe heart-, lung, liver- or kidney disease, cancer, malnutrition and other medical conditions causing fragility
- Performed bariatric revisional surgery
- Drug- or alcohol abuse
- Pregnancy
- Use of acarbose or octreotide in the treatment of postprandial hypoglycemia
- Use of continuous glucose monitor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust
Tønsberg, Vestfold, 3103
Heidi Borgeraas, PhD, +47 46707000, heibor@siv.no
Dag Hofsø, MD, PhD, +47 90591666, dag.hofso@siv.no
About this study
Official title: Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial
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?
Read more
Researchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia.
Participants will:
- Use a continuous glucose monitor for 6 weeks or use no continuous glucose monitor for 5 weeks and wear a blinded continuous glucose monitor for 1 week.
- Visit the clinic 2-3 times and have 2-3 phone consultations.
- Register symptoms of hypoglycaemia, answer questionnaires, undergo a 24-hour dietary recall interview conducted by a registered dietitian, measure weight and body composition and take blood samples.
- Conditions
- Hypoglycemia Non-Diabetic, Gastric Bypass Surgery
- Being tested
- Continuous glucose monitor (Dexcom® G7)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitor (Dexcom® G7)Device
Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous glucose monitor (Dexcom® G7) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: Screening (week 0) and week 6
Secondary outcomes (3)
• 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.
Measured: Screening (week 0) and week 6
• 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.
Measured: 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.
Measured: Screening (week 0) and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start12 Nov 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemia Non-DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Borgeraas, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468865
- Sponsor's protocol ID
- 596343
- Acronym
- HypoSurge
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06468865
- Acronym / sponsor ID
- HypoSurge / 596343
- Conditions
- Hypoglycemia Non-Diabetic, Gastric Bypass Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Study start
- 12 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Use a continuous glucose monitor for 6 weeks or use no continuous glucose monitor for 5 weeks and wear a blinded continuous glucose monitor for 1 week.
- Visit the clinic 2-3 times and have 2-3 phone consultations.
- Register symptoms of hypoglycaemia, answer questionnaires, undergo a 24-hour dietary recall interview conducted by a registered dietitian, measure weight and body composition and take blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitor | Experimental | Device: Continuous glucose monitor (Dexcom® G7)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gastric bypass surgery at least 1 year ago
- Age ≥18 years
- Symptomatic postprandial hypoglycaemia; capillary glucose level <3.0 mmol/L 1-4 hours after meals
Key exclusion criteria (12 listed)
- Not able to give informed consent
- Reduced compliance due to severe mental and psychiatric conditions
- Use of insulin or sulfonylureas
- Use of systemic corticosteroids
- Primary or secondary adrenal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitor (Dexcom® G7)Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes | Device | Continuous glucose monitor |
Primary outcome
• 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.
Time frame: Screening (week 0) and week 6
Interstitial glucose is measured for one week during the screening week and for one week during week 6.
3 secondary outcomes
• 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.
Time frame: Screening (week 0) and week 6
• 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.
Time frame: 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.
Time frame: Screening (week 0) and week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitor (Dexcom® G7) in people with Hypoglycemia Non-Diabetic and Gastric Bypass Surgery, run by Sykehuset i Vestfold HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Borgeraas, PhD (004746707000, heibor@siv.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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. (time frame: Screening (week 0) and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.