Type 1 Diabetes Mellitus With HypoglycemiaIHART-CGMNCT03028220
Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data
A study testing Dexcom G5 Continuous Glucose Monitor and Abbott Freestyle Libre in people with Type 1 Diabetes Mellitus With Hypoglycemia and Impaired Awareness of Hypoglycemia, run by Imperial College London.
Trial summary
This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus With Hypoglycemia, Impaired Awareness of Hypoglycemia, Type1diabetes
- What is being tested?
- Dexcom G5 Continuous Glucose Monitor and Abbott Freestyle Libre
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age
- Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
- Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4
- Type 1 diabetes for greater than 3 years
- On an intensified multiple dose insulin injection regimen for > 6 months (MDI)
- Previous type 1 diabetes structured education (either group or 1:1)
Who cannot join
- Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
- Use of regular paracetamol
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials, except at the discretion of the chief investigator
- Have active malignancy or under investigation for malignancy
Show all 9Show fewer
- Severe visual impairment
- Reduced manual dexterity
- Unable to participate due to other factors, as assessed by the Chief Investigators
About this study
Official title: Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.
Read the detailed description
Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.
The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).
- Conditions
- Type 1 Diabetes Mellitus With Hypoglycemia, Impaired Awareness of Hypoglycemia, Type1diabetes
- Being tested
- Dexcom G5 Continuous Glucose Monitor, Abbott Freestyle Libre
- Keywords
- Type 1 Diabetes, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G5 Continuous Glucose MonitorDevice
Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values
Abbott Freestyle LibreDevice
Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data
| Study group | Role | What they receive |
|---|---|---|
| Real time continuous glucose monitoring | Active comparator | Use of Dexcom G5 continuous glucose monitoring Receives: Device: Dexcom G5 Continuous Glucose Monitor |
| Flash glucose monitoring | Active comparator | Use of Abbott FreeStyle Libre flash glucose monitoring Receives: Device: Abbott Freestyle Libre |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline
Measured: 10 weeks
Secondary outcomes (11)
% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline
Measured: 10 weeks
% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint
Measured: 10 weeks
% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint
Measured: 10 weeks
% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)
Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint
Measured: 10 weeks
% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)
Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint
Measured: 10 weeks
% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
% time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint
Measured: 10 weeks
Hypoglycemia
Number of participants with hypoglycemic excursions
Measured: 8 weeks
Severe Hypoglycaemia
Number of participants with episodes of severe hypoglycaemia
Measured: 8 weeks
Changes in Glucose Variability Measured
Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1
Measured: 8 weeks
Glucose Variability Measured by MAGE
Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)
Measured: 8 weeks
Glucose Variability Measured by CONGA
Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionAug 2017
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 Type 1 Diabetes Mellitus With HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Oliver, FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028220
- Sponsor's protocol ID
- 15HH2875
- Acronym
- IHART-CGM
- Status last verified
- Oct 2019
- First submitted
- 16 Dec 2016
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avari P, Moscardo V, Jugnee N, Oliver N, Reddy M. Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes. J Diabetes Sci Technol. 2020 May;14(3):567-574. doi: 10.1177/1932296819867688. Epub 2019 Aug 2.
PubMed 31375042Reddy M, Jugnee N, El Laboudi A, Spanudakis E, Anantharaja S, Oliver N. A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia. Diabet Med. 2018 Apr;35(4):483-490. doi: 10.1111/dme.13561. Epub 2017 Dec 29.
PubMed 29230878
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
- ClinicalTrials.gov ID
- NCT03028220
- Acronym / sponsor ID
- IHART-CGM / 15HH2875
- Conditions
- Type 1 Diabetes Mellitus With Hypoglycemia, Impaired Awareness of Hypoglycemia, Type1diabetes
- Keywords
- Type 1 Diabetes, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.
Detailed description
Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.
The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real time continuous glucose monitoring | Active comparator | Device: Dexcom G5 Continuous Glucose MonitorUse of Dexcom G5 continuous glucose monitoring |
| Flash glucose monitoring | Active comparator | Device: Abbott Freestyle LibreUse of Abbott FreeStyle Libre flash glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults over 18 years of age
- Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
- Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4
- Type 1 diabetes for greater than 3 years
- On an intensified multiple dose insulin injection regimen for > 6 months (MDI)
Key exclusion criteria (9 listed)
- Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
- Use of regular paracetamol
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials, except at the discretion of the chief investigator
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 G5 Continuous Glucose MonitorReal time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values | Device | Real time continuous glucose monitoring |
| Abbott Freestyle LibreContinuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data | Device | Flash glucose monitoring |
Primary outcome
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
Time frame: 10 weeks
Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline
11 secondary outcomes
% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
Time frame: 10 weeks
% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
Time frame: 10 weeks
% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
Time frame: 10 weeks
% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)
Time frame: 10 weeks
% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)
Time frame: 10 weeks
% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
Time frame: 10 weeks
Hypoglycemia
Time frame: 8 weeks
Severe Hypoglycaemia
Time frame: 8 weeks
Changes in Glucose Variability Measured
Time frame: 8 weeks
Glucose Variability Measured by MAGE
Time frame: 8 weeks
Glucose Variability Measured by CONGA
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31375042Avari P, Moscardo V, Jugnee N, Oliver N, Reddy M. Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes. J Diabetes Sci Technol. 2020 May;14(3):567-574. doi: 10.1177/1932296819867688. Epub 2019 Aug 2.
- Derived from this study: PubMed 29230878Reddy M, Jugnee N, El Laboudi A, Spanudakis E, Anantharaja S, Oliver N. A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia. Diabet Med. 2018 Apr;35(4):483-490. doi: 10.1111/dme.13561. Epub 2017 Dec 29.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus With Hypoglycemia
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Recruiting
Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
Diabetes (DM), Diabetes Mellitus
Not yet recruitingPhase 1/2
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
Diabete Mellitus, Diabete Type 1
RecruitingPhase 1/2
Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
Diabetes Mellitus, Type 1
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.
Nick Oliver, FRCP principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G5 Continuous Glucose Monitor and Abbott Freestyle Libre in people with Type 1 Diabetes Mellitus With Hypoglycemia and Impaired Awareness of Hypoglycemia, run by Imperial College London.
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 6 inclusion and 9 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 16 Apr 2019). 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?
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL) (time frame: 10 weeks). 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 NCT03028220, 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 13 Nov 2019.