Trial reportNature communications2022
A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc).
Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02940873 (Beyond Education), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Beyond Education: A Hypoglycaemia Awareness Restoration Programme for People With Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc)
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- 2023 Clinical Practice Guidelines for Diabetes Management in Korea: Full Version Recommendation of the Korean Diabetes Association.Diabetes & metabolism journal · 2024Guideline
- A pilot trial of 'HypoPals': Assessing trial procedures feasibility and intervention acceptability for a prospective digital hypoglycemia behavioral intervention study.Contemporary clinical trials · 2026Trial
- Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.Diabetic medicine : a journal of the British Diabetic Association · 2024Trial
- Hypoglycaemia Was Not Associated With Depression, Anxiety, Diabetes Distress or Fear of Hypoglycaemia Scores in People With Type 1 or Insulin-Treated Type 2 Diabetes in the Hypo-METRICS Study.Diabetes, obesity & metabolism · 2026Article
- Unconscious uncoupling: dysfunctional neurovascular responses to low glucose in type 1 diabetes and impaired hypoglycemia awareness.The Journal of clinical investigation · 2026Article
- Assessing thoughts, feelings and behaviours related to hypoglycaemia: Psychometric evaluation of the Hypoglycaemia Cues Questionnaire (HypoC-Q).Diabetic medicine : a journal of the British Diabetic Association · 2026Article
- Associations between impaired awareness of hypoglycaemia and mental health in insulin-treated type 2 and type 1 diabetes in the Hypo-METRICS study.Diabetic medicine : a journal of the British Diabetic Association · 2026Observational
- Interoceptive Awareness Moderates the Relationship Between Hypoglycemia Exposure and Symptom Recognition in Adults With Type 1 Diabetes.Diabetes care · 2026Article
- Psychoeducation for adults with type 1 diabetes and problematic hypoglycemia: implementation analysis of a clinical trial (HARPdoc).Frontiers in health services · 2026Article
- 6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes-2026.Diabetes care · 2026Review
- Impaired awareness of hypoglycemia: can structured education address this persistent challenge?Frontiers in endocrinology · 2026Review
- Characterizing Severe and Level 2 Hypoglycemia and Associated Risk Factors in Adults with Type 1 Diabetes Using Hybrid Closed-Loop Insulin Pumps.Diabetes technology & therapeutics · 2025Article
- Predictors of impaired awareness of hypoglycaemia and severe hypoglycaemia in adults with type 1 diabetes.Diabetic medicine : a journal of the British Diabetic Association · 2025Article
- Impaired Awareness and Symptomatology of Hypoglycemia in Adults With Type 1 Diabetes Using Continuous Glucose Monitoring.The Journal of clinical endocrinology and metabolism · 2025Article
- 2025 Clinical Practice Guidelines for Diabetes Management in Korea: Recommendation of the Korean Diabetes Association.Diabetes & metabolism journal · 2025Article
- Recurrent Hypoglycemic Coma Episodes Associated With Primary Biliary Cirrhosis.JCEM case reports · 2025Article
- Associations between clustering of hypoglycemic symptoms, psychological traits, and problem-solving abilities in adults with type 1 diabetes: baseline data analysis of the PR-IAH study.Diabetology international · 2025Article
- Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial.The Lancet regional health. Europe · 2025Article
- The impact of technology on impaired awareness of hypoglycaemia in type 1 diabetes.Therapeutic advances in endocrinology and metabolism · 2025Review
- 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2025.Diabetes care · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 8 institutions in 2 countries.
Funding
Abstract
Impaired awareness of hypoglycaemia (IAH) is a major risk for severe hypoglycaemia in insulin treatment of type 1 diabetes (T1D). To explore the hypothesis that unhelpful health beliefs create barriers to regaining awareness, we conducted a multi-centre, randomised, parallel, two-arm trial (ClinicalTrials.gov NCT02940873) in adults with T1D and treatment-resistant IAH and severe hypoglycaemia, with blinded analysis of 12-month recall of severe hypoglycaemia at 12 and/or 24 months the primary outcome. Secondary outcomes included cognitive and emotional measures. Adults with T1D, IAH and severe hypoglycaemia despite structured education in insulin adjustment, +/- diabetes technologies, were randomised to the "Hypoglycaemia Awareness Restoration Programme despite optimised self-care" (HARPdoc, n = 49), a psychoeducation programme uniquely focussing on changing cognitive barriers to avoiding hypoglycaemia, or the evidence-based "Blood Glucose Awareness Training" (BGAT, n = 50), both delivered over six weeks. Median [IQR] severe hypoglycaemia at baseline was 5[2-12] per patient/year, 1[0-5] at 12 months and 0[0-2] at 24 months, with no superiority for HARPdoc (HARPdoc vs BGAT incident rate ratios [95% CI] 1.25[0.51, 3.09], p = 0.62 and 1.26[0.48, 3.35], p = 0.64 respectively), nor for changes in hypoglycaemia awareness scores or fear. Compared to BGAT, HARPdoc significantly reduced endorsement of unhelpful cognitions (Estimated Mean Difference for Attitudes to Awareness scores at 24 months, -2.07 [-3.37,-0.560], p = 0.01) and reduced scores for diabetes distress (-6.70[-12.50,-0.89], p = 0.02); depression (-1.86[-3.30, -0.43], p = 0.01) and anxiety (-1.89[-3.32, -0.47], p = 0.01). Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more effective than BGAT at reducing severe hypoglycaemia.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.