Hypoglycemia, ReactiveNCT03353415
Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery
A study testing Dexcom CGM masked and Dexcom CGM unmasked in people with Hypoglycemia, Reactive and Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to see if the use of a continuous glucose monitor (CGM) by people who experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number and severity of low blood sugar episodes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypoglycemia, Reactive, Hypoglycemia
- What is being tested?
- Dexcom CGM masked and Dexcom CGM unmasked
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 12 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females diagnosed with ongoing post-bariatric or post-gastric surgery hypoglycemia with prior episodes of neuroglycopenia
- Age 18-65 years of age, inclusive, at screening
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
Who cannot join
- Documented hypoglycemia occurring in the fasting state (> 12 hours fast);
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin >2.0;
- Congestive heart failure, New York Heart Association (NYHA) class II, Ill or IV;
- History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
- History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
Show all 22Show fewer
- Concurrent administration of beta-blocker therapy;
- History of a cerebrovascular accident;
- Seizure disorder (other than with suspect or documented hypoglycemia);
- Active treatment with any diabetes medications except for acarbose;
- Active treatment with octreotide or diazoxide;
- Active malignancy, except basal cell or squamous cell skin cancers;
- Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia (MEN) 2, neurofibromatosis, or Von Hippel-Lindau disease);
- Known insulinoma;
- Major surgical operation within 30 days prior to screening;
- Hematocrit< 33%;
- Bleeding disorder, treatment with warfarin, or platelet count <50,000;
- Blood donation (1 pint of whole blood) within the past 2 months;
- Active alcohol abuse or substance abuse;
- Current administration of oral or parenteral corticosteroids;
- Pregnancy and/ or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill/patch I vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Use of an investigational drug within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Efficacy of Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety in Patients With Hypoglycemia After Gastric Surgery
The purpose of this study is to see if the use of a continuous glucose monitor (CGM) by people who experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number and severity of low blood sugar episodes.
Read the detailed description
The CGM devices used in this study are approved by the Food and Drug Administration (FDA) for monitoring the glucose levels of people with diabetes. The investigators of this study are looking to see if these CGM devices are able to benefit people who have had gastric surgery and experience low blood sugar episodes, which can be asymptomatic and lead to complications, impairing safety. This study involves wearing a CGM sensor/transmitter during first a masked phase (unable to see CGM sensor glucose levels), followed by an unmasked phase (able to see and respond to sensor glucose levels and alarms). Participants are asked to regularly record fingerstick (capillary) blood sugar values and any symptoms experienced, as well as a record of treatments for symptoms and glucose levels.
Participants attend three to five study visits: 5 visits for participants who wore the Dexcom G4, and 3 visits for participants who wore the Dexcom G6. The Dexcom G4 became unavailable during the course of the study when the G6 was introduced. (The Dexcom G4 had a 7 day wear period versus a 10 day wear period for the G6. As the G6 has a longer wear period, the frequency of the study visits was able to be decreased).
This study also involves the use of a fitness tracker, which will be worn for the duration of the study and returned at the end of the study.
Participants wearing the Dexcom G4 device were able to keep the Dexcom G4 CGM receiver and transmitter (this was not possible with the Dexcom G6 system).
- Conditions
- Hypoglycemia, Reactive, Hypoglycemia
- Being tested
- Dexcom CGM masked, Dexcom CGM unmasked
- Keywords
- Post-bariatric Hypoglycemia;
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom CGM maskedDevice
The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
Dexcom CGM unmaskedDevice
During the second phase (2 weeks for the Dexcom G4 and 10 days for the Dexcom G6), participants are able to see the sensor glucose levels displayed from the CGM. Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
| Study group | Role | What they receive |
|---|---|---|
| Masked CGM Wear (Phase 1) | Other | Each participant will wear the Dexcom CGM for two sequential phases. During the first phase, participants will not be able to read the sensor glucose levels (masked). Receives: Device: Dexcom CGM masked |
| Unmasked CGM Wear (Phase 2) | Experimental | In the second phase, participants will be able to read the sensor glucose levels (unmasked). Frequency of hypoglycemia will be compared between the two phases of the study. Receives: Device: Dexcom CGM unmasked |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase.
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <70 mg/dl, comparing the masked versus the unmasked phases.
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases.
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases.
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Secondary outcomes (18)
Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
expressed as median and median standard deviation
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear
The sensor glucose level range is derived from the difference between the highest sensor glucose levels minus the lowest sensor glucose level (mg/dL).
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Mean Coefficient of Variation of Sensor Glucose Data During Period of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Mean Amplitude of Glycemic Excursion (MAGE) of Sensor Glucose Levels During Periods of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
CONGA assesses glucose variability within a predetermined time window - 24 hours in this case. Calculation of this parameter is based on the assessment of the differences between glucose values measured at regular time intervals, then on the standard deviation (SD) of these differences
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
4 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Total Number of Hypoglycemic Events During the Masked Versus the Unmasked Phases of CGM Wear, as Defined by a Sensor Glucose <70 mg/dL, for at Least 15 Minutes
Hypoglycemic events are defined as having glucose <70 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data.
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Total Number of Hypoglycemic Events Defined by a Sensor Glucose <60 mg/dL, for at Lease 15 Minutes, During the Masked Versus Unmasked CGM Phase
Hypoglycemic events are defined as having glucose <60 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data.
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Total Number of Hypoglycemic Events Defined by a Sensor Glucose <54 mg/dL, for at Least 15 Minutes, During the Masked Versus Unmasked CGM Phase
Hypoglycemic events are defined as having glucose <54 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data.
Measured: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start7 Feb 2019
- Primary completion11 Nov 2021
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypoglycemia, ReactiveStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Specifically, we will analyze glycemic patterns during a phase of baseline masked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6), in comparison to a sequential, second phase of unmasked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6). Please note that we have chosen to have a consistent masked monitoring first, as providing unmasked data to participants first could alter their dietary or other patterns and reduce ability of the study to independently assess efficacy of the CGM intervention.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Mary Elizabeth Patti, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353415
- Sponsor's protocol ID
- 2017-27
- Status last verified
- Aug 2023
- First submitted
- 21 Nov 2017
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Patti ME, Goldfine AB. The rollercoaster of post-bariatric hypoglycaemia. Lancet Diabetes Endocrinol. 2016 Feb;4(2):94-6. doi: 10.1016/S2213-8587(15)00460-X. Epub 2015 Dec 15. No abstract available.
PubMed 26701701Cummings C, Jiang A, Sheehan A, Ferraz-Bannitz R, Puleio A, Simonson DC, Dreyfuss JM, Patti ME. Continuous glucose monitoring in patients with post-bariatric hypoglycaemia reduces hypoglycaemia and glycaemic variability. Diabetes Obes Metab. 2023 Aug;25(8):2191-2202. doi: 10.1111/dom.15096. Epub 2023 May 3.
PubMed 37046360
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy of Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety in Patients With Hypoglycemia After Gastric Surgery
- ClinicalTrials.gov ID
- NCT03353415
- Acronym / sponsor ID
- 2017-27
- Conditions
- Hypoglycemia, Reactive, Hypoglycemia
- Keywords
- Post-bariatric Hypoglycemia;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the use of a continuous glucose monitor (CGM) by people who experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number and severity of low blood sugar episodes.
Detailed description
The CGM devices used in this study are approved by the Food and Drug Administration (FDA) for monitoring the glucose levels of people with diabetes. The investigators of this study are looking to see if these CGM devices are able to benefit people who have had gastric surgery and experience low blood sugar episodes, which can be asymptomatic and lead to complications, impairing safety. This study involves wearing a CGM sensor/transmitter during first a masked phase (unable to see CGM sensor glucose levels), followed by an unmasked phase (able to see and respond to sensor glucose levels and alarms). Participants are asked to regularly record fingerstick (capillary) blood sugar values and any symptoms experienced, as well as a record of treatments for symptoms and glucose levels.
Participants attend three to five study visits: 5 visits for participants who wore the Dexcom G4, and 3 visits for participants who wore the Dexcom G6. The Dexcom G4 became unavailable during the course of the study when the G6 was introduced. (The Dexcom G4 had a 7 day wear period versus a 10 day wear period for the G6. As the G6 has a longer wear period, the frequency of the study visits was able to be decreased).
This study also involves the use of a fitness tracker, which will be worn for the duration of the study and returned at the end of the study.
Participants wearing the Dexcom G4 device were able to keep the Dexcom G4 CGM receiver and transmitter (this was not possible with the Dexcom G6 system).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Specifically, we will analyze glycemic patterns during a phase of baseline masked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6), in comparison to a sequential, second phase of unmasked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6). Please note that we have chosen to have a consistent masked monitoring first, as providing unmasked data to participants first could alter their dietary or other patterns and reduce ability of the study to independently assess efficacy of the CGM intervention.
| Arm | Type | Receives |
|---|---|---|
| Masked CGM Wear (Phase 1) | Other | Device: Dexcom CGM maskedEach participant will wear the Dexcom CGM for two sequential phases. During the first phase, participants will not be able to read the sensor glucose levels (masked). |
| Unmasked CGM Wear (Phase 2) | Experimental | Device: Dexcom CGM unmaskedIn the second phase, participants will be able to read the sensor glucose levels (unmasked). Frequency of hypoglycemia will be compared between the two phases of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females diagnosed with ongoing post-bariatric or post-gastric surgery hypoglycemia with prior episodes of neuroglycopenia
- Age 18-65 years of age, inclusive, at screening
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
Key exclusion criteria (22 listed)
- Documented hypoglycemia occurring in the fasting state (> 12 hours fast);
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin >2.0;
- Congestive heart failure, New York Heart Association (NYHA) class II, Ill or IV;
- History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
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 |
|---|---|---|
| Dexcom CGM maskedThe CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)). The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation). | Device | Masked CGM Wear (Phase 1) |
| Dexcom CGM unmaskedDuring the second phase (2 weeks for the Dexcom G4 and 10 days for the Dexcom G6), participants are able to see the sensor glucose levels displayed from the CGM. Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop. The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation). | Device | Unmasked CGM Wear (Phase 2) |
Primary outcome
Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase.
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <70 mg/dl, comparing the masked versus the unmasked phases.
Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases.
Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases.
18 secondary outcomes
Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Mean Coefficient of Variation of Sensor Glucose Data During Period of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Mean Amplitude of Glycemic Excursion (MAGE) of Sensor Glucose Levels During Periods of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
4 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Total Number of Hypoglycemic Events During the Masked Versus the Unmasked Phases of CGM Wear, as Defined by a Sensor Glucose <70 mg/dL, for at Least 15 Minutes
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Total Number of Hypoglycemic Events Defined by a Sensor Glucose <60 mg/dL, for at Lease 15 Minutes, During the Masked Versus Unmasked CGM Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Total Number of Hypoglycemic Events Defined by a Sensor Glucose <54 mg/dL, for at Least 15 Minutes, During the Masked Versus Unmasked CGM Phase
Time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26701701Patti ME, Goldfine AB. The rollercoaster of post-bariatric hypoglycaemia. Lancet Diabetes Endocrinol. 2016 Feb;4(2):94-6. doi: 10.1016/S2213-8587(15)00460-X. Epub 2015 Dec 15. No abstract available.
- Results publication: PubMed 37046360Cummings C, Jiang A, Sheehan A, Ferraz-Bannitz R, Puleio A, Simonson DC, Dreyfuss JM, Patti ME. Continuous glucose monitoring in patients with post-bariatric hypoglycaemia reduces hypoglycaemia and glycaemic variability. Diabetes Obes Metab. 2023 Aug;25(8):2191-2202. doi: 10.1111/dom.15096. Epub 2023 May 3.
- Individual participant dataSharing planned: No
Related trials for Hypoglycemia, Reactive
RecruitingPhase 4
Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)
Hypoglycemia, Hypoglycemia, Reactive
Not yet recruitingPhase 2
Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal Disease
Postprandial Hypoglycemia, End-stage Renal Disease (ESRD)
Active, not recruitingPhase 4
Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia
Hypoglycemia, Hypoglycemia, Reactive
Recruiting
Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome
RecruitingObservational study
External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia
Hypoglycemia, Cerebral Blood Flow
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. This study is not recruiting at the moment.
Mary Elizabeth Patti, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom CGM masked and Dexcom CGM unmasked in people with Hypoglycemia, Reactive and Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
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 22 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: finished, as of the sponsor's last update on 28 Aug 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase. (time frame: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353415, which also lists 2 linked publications.
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 28 Aug 2023.