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NCT02940873 · ClinicalTrials.gov registry record · NA
Hypoglycaemia Awareness Restoration Programme
A NA study, sponsored by King's College London.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
NCT02940873 is a NA study that has completed, run by King's College London. The registered enrollment target is 99 participants.
The verdict
NCT02940873, a NA study, has completed, sponsored by King's College London.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
Study Summary
Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH), increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe hypoglycaemia reduced when people are taught how to adjust their insulin around their life-styles through structured education but problematic hypoglycaemia may persist. Many people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts about hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot benefit from conventional treatments to reduce hypoglycaemia. The investigators developed the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that combines revision of knowledge about hypoglycaemia avoidance with psychological therapies that directly address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over six weeks, by diabetes educators to groups of 6 people. In a pilot study, severe hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and recurrent severe hypoglycaemia. The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an established educational intervention (Blood Glucose Awareness Training, BGAT) which has also been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic hypoglycaemia persisting despite otherwise optimised insulin self-management will be recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4 centres. The investigators will measure severe hypoglycaemia over two years following courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.
Interventions
- BEHAVIORAL HARPdoc courses
- BEHAVIORAL BGAT courses
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2017-03-09 |
| Est. Completion | 2021-04-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02940873
The ClinicalTrials.gov registry entry for NCT02940873 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is King's College London, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which HARPdoc courses is the first listed.
NCT02940873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02940873 about?
NCT02940873 is a clinical study titled "Hypoglycaemia Awareness Restoration Programme". Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH), increases risk of severe h...
What is the current status of trial NCT02940873?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2017-03-09. Estimated completion is 2021-04-27.
What interventions are being tested in trial NCT02940873?
The interventions under investigation include: HARPdoc courses (BEHAVIORAL), BGAT courses (BEHAVIORAL).
Who is sponsoring clinical trial NCT02940873?
This trial is sponsored by King's College London, which has 5 total clinical trials registered on ClinicalTrials.gov.
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