Monitoring Techniques for Post-Bariatric Hypoglycemia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Sulfonylureas, others

Disqualifiers: Insulinoma, Infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some people experience severe low blood sugar after gastric bypass surgery. Researchers will use devices such as the Cardea Solo monitor and continuous glucose monitors (CGM) to track blood sugar levels under various conditions. Participants may need to attend clinic visits or use a CGM at home. Suitable candidates for this trial include individuals who had bariatric surgery over six months ago and have experienced low blood sugar episodes. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance post-surgery care for others.

Will I have to stop taking my current medications?

The trial requires that you stop taking sulfonylureas or other medications that affect glucose metabolism at least 5 half-lives before participating. If you're on these medications, you will need to stop them before joining the study.

What prior data suggests that these monitoring techniques are safe for post-bariatric hypoglycemia patients?

Research has shown that using a Continuous Glucose Monitor (CGM) can help manage blood sugar levels for individuals who have undergone bariatric surgery. Studies have found that CGMs can reduce episodes of low blood sugar and help maintain more stable blood sugar levels. However, CGMs are not officially approved for diagnosing low blood sugar in individuals without diabetes, so they should be used with caution.

Regarding safety, CGMs are generally well-tolerated. Some studies report that CGMs can effectively reduce the number of low blood sugar events, indicating a positive safety profile. However, like any device, there may be minor risks or discomforts, such as skin irritation at the attachment site.

The other device in the trial, Cardea Solo monitoring, isn't specifically mentioned in the provided sources. However, similar devices are usually non-invasive and considered safe for most individuals.

Prospective trial participants should consult a medical professional about any concerns regarding these devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative monitoring techniques for managing post-bariatric hypoglycemia, a condition that can be challenging to control with standard care options like dietary changes and medication. The trial is testing the use of the Cardea Solo monitoring system and Continuous Glucose Monitors (CGMs) to provide more precise and continuous insights into blood sugar levels. This approach could allow for real-time adjustments and more personalized treatment plans, potentially improving outcomes for patients who struggle with frequent hypoglycemic episodes. By evaluating these advanced monitoring technologies, researchers hope to refine management strategies and enhance the quality of life for individuals affected by this condition.

What evidence suggests that these monitoring techniques are effective for post-bariatric hypoglycemia?

Research has shown that continuous glucose monitoring (CGM), one of the techniques studied in this trial, can assist people with low blood sugar after weight-loss surgery. One study found that 75% of patients who underwent gastric bypass surgery experienced low blood sugar levels detected by CGM, even without noticeable symptoms. Another study found that about 66% of patients had at least one low blood sugar episode during the day. These findings suggest that CGM can effectively track these episodes, potentially improving condition management. Additionally, CGM might aid in weight loss and reduce post-meal symptoms for some patients. ^{2 4 5 6 7}

Who Is on the Research Team?

Tracey L McLaughlin, MD

Principal Investigator

Stanford University

Colleen Craig, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who've had bariatric surgery over 6 months ago and have documented low blood sugar due to high insulin. It's not for those with a tumor causing high insulin, recent acute illness, pregnant or breastfeeding women, or anyone on certain diabetes drugs.

Inclusion Criteria

I had weight loss surgery over 6 months ago.

I have a history of low blood sugar due to high insulin levels.

Exclusion Criteria

I have not had a serious infection or illness in the last 2 weeks.

I have or had an insulin-producing tumor.

Allergy to test meal or medications used in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote Phase

Participants wear a continuous glucose monitor (CGM) in a blinded manner for 20 days followed by an unblinded manner for another 20 days

40 days

Remote monitoring

In-Clinic Phase

Participants undergo metabolic assessments through standardized mixed meal tolerance tests and other procedures over 1-3 visits

Approximately 2 months

1-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main trial phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Use of Cardea Solo monitoring
• Use of Continuous Glucose Monitor (CGM)

Trial Overview The study tests how 'Cardea Solo' monitoring and Continuous Glucose Monitors (CGM) can help understand why some patients develop severe hypoglycemia after gastric bypass surgery. The goal is to improve prediction and treatment of this condition.

How Is the Trial Designed?

Group I: Remote Phase: Post-Bariatric Hypoglycemia Patients Experimental Treatment 2 Interventions

Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.

Group II: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube Active Control 1 Intervention

Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed.

Group III: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients Active Control 1 Intervention

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants.

Group IV: In-Clinic Phase: Nonsurgical Controls Active Control 1 Intervention

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.

Group V: In-Clinic Phase: Surgical Controls Active Control 1 Intervention

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

Post-bariatric hypoglycemia (PBH) occurs in over half (54.3%) of patients after bariatric surgery, with nocturnal PBH affecting about 16.4% of patients, indicating a significant risk following these procedures.

The rates of PBH are similar for Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), but RYGB is associated with greater glycemic variability, and the likelihood of experiencing PBH increases over time after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of post-bariatric hypoglycemia using continuous glucose monitoring: A meta-analysis of literature studies. Lupoli, R., Lembo, E., Rainone, C., et al.[2022]

Continuous glucose monitoring (CGM) effectively demonstrated increased glycemic variability in individuals who underwent Roux-en-Y gastric bypass (RYGB) and showed that a low-carbohydrate diet significantly reduced this variability.

However, CGM overestimated actual blood glucose levels by about 1.1 mmol/l in the hypoglycemic range, which is important to consider when using CGM for diagnosing hypoglycemia in RYGB patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring After Gastric Bypass to Evaluate the Glucose Variability After a Low-Carbohydrate Diet and to Determine Hypoglycemia. Nielsen, JB., Abild, CB., Pedersen, AM., et al.[2019]

A novel system using continuous glucose monitoring (CGM) and a glucagon delivery pump successfully predicted and managed hypoglycemia in seven participants with postbariatric hypoglycemia (PBH), demonstrating safety and feasibility.

After initial adjustments to the glucagon dosage and algorithm, the system effectively increased the time participants spent above the hypoglycemia threshold, indicating improved management of hypoglycemic episodes without causing severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Clinical Evaluation of a Novel Low-Glucose Prediction Algorithm with Mini-Dose Stable Glucagon Delivery in Post-Bariatric Hypoglycemia. Laguna Sanz, AJ., Mulla, CM., Fowler, KM., et al.[2019]

Continuous glucose monitoring (CGM) effectively identified hypoglycemic episodes in a patient after gastric bypass surgery, which were not detected during a 72-hour fasting period, highlighting its utility in diagnosing hypoglycemia that may be confused with dumping syndrome.

After implementing dietary changes and treatment with acarbose, no further hypoglycemic episodes occurred over an 8-month follow-up, demonstrating the potential for CGM to monitor treatment success in managing these episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of continuous glucose monitoring for the diagnosis of hypoglycemia after a gastric bypass in a patient previously treated for type 2 diabetes. Hanaire, H., Dubet, A., Chauveau, ME., et al.[2021]

Continuous glucose monitoring (CGM) significantly reduces the time patients with post-bariatric hypoglycaemia (PBH) spend in hypoglycaemia when they have access to real-time data and alarms, with a median reduction from 1.4% to 0.7% for severe hypoglycaemia (<60 mg/dL).

CGM also helps maintain better overall glucose levels, allowing patients to spend more time in the normal glucose range (70-180 mg/dL) and reducing glycaemic variability, which can enhance safety for those with hypoglycaemia unawareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in patients with post-bariatric hypoglycaemia reduces hypoglycaemia and glycaemic variability. Cummings, C., Jiang, A., Sheehan, A., et al.[2023]

Continuous glucose monitoring (CGM) revealed that patients who underwent gastric bypass surgery often experience high glucose variability and hypoglycemia, which can significantly affect their daily activities and metabolic health.

Implementing a low glycemic index diet helped reduce glucose variability and hypoglycemic episodes in both patients, highlighting the importance of dietary management and psychological support in improving their overall health post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in the management of patients after gastric bypass Rodríguez Flores, M., Cruz Soto, RC., Vázquez Velázquez, V., et al.[2020]

Continuous glucose monitoring (CGM) is primarily used in post-bariatric surgery patients to analyze glucose patterns and evaluate glycemic treatment outcomes, with most studies utilizing CGM for 3-7 days in a blinded mode.

The accuracy of CGM devices, such as the Freestyle Libre, was reported in only one study, showing a mean absolute relative difference of 21.7%, indicating a need for further research on the effectiveness of CGM in improving glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Continuous Glucose Monitoring in Patients Following Bariatric Surgery: A Scoping Review. Yu, Y., Groth, SW.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10807851/

Continuous glucose monitoring in patients with post- ... One study using continuous glucose monitoring (CGM) found that 75% of asymptomatic post-RYGB patients had sensor glucose levels below 3.1 mM/L (55 mg/dL).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07095972

Continuous Glucose Monitoring in Metabolic Surgery Outcomes Data: Weight loss, diabetes remission status, insulin sensitivity measures, and occurrence of post-bariatric hypoglycemia (PBH). Safety Data: Adverse ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728925008354

Hypoglycemia Following Metabolic and Bariatric Surgery ... CGM data showed that ∼66% of participants experienced at least one possible daytime hypoglycemic event (range = 1-23 episodes/person). The total ...

4. mdpi.com mdpi.com/2571-841X/8/4/200/pdf?version=1759895936

Continuous Glucose Monitoring Improves Weight Loss and ... While further studies are needed, this case suggests CGM may benefit similar patients experiencing postprandial symptoms or weight regain after ...

5. ccjm.org ccjm.org/content/92/2/103

Hypoglycemia after bariatric surgery: Management updates A recently published meta-analysis of data from studies that assessed post–bariatric surgery hypoglycemia (PBH) by continuous glucose monitoring ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37046360/

Continuous glucose monitoring in patients with post-bariatric ... Real-time CGM data and alarms are associated with reductions in low sensor glucose, elevated sensor glucose, and glycaemic variability.

7. academic.oup.com academic.oup.com/jes/advance-article/doi/10.1210/jendso/bvaf106/8166576

Continuous Glucose Monitoring in Patients With Postbariatric ... Symptom-triggered hypoglycemic events confirmed by fingerstick glucose were reduced 6-fold (P = .008) and the glucose nadir measured by CGM was >8 mg/dL higher ...