CompletedNot Applicable

Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data

40 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Severe visual impairment * Reduced manual dexterity * Unable to participate due to other factors, as assessed by the Chief Investigators

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)

Timeframe: 10 weeks

Trial details

NCT IDNCT03028220

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02

Results submitted2018-08-10

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus With Hypoglycemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.