Background (150–200)
Methods
Search strategy
Eligibility criteria
Assessment of trial eligibility
Data extraction
Outcome classification
Results
Search results and study characteristics
n (%) | |
---|---|
Year | |
2009 | 1 (1) |
2010 | 0 (0) |
2011 | 2 (1) |
2012 | 3 (2) |
2013 | 6 (4) |
2014 | 21 (15) |
2015 | 49 (36) |
2016 | 56 (41) |
Phase | |
3 | 48 (35) |
4 | 90 (65) |
Planned enrolment (median and range) | 135 (12–5000) |
Region of worka
| |
Asia | 55 (40) |
Europe | 45 (33) |
North America | 46 (33) |
South America | 8 (6) |
Africa | 6 (4) |
Central America | 4 (3) |
Australia | 1 (1) |
Not reported | 6 (4) |
Trial design | |
Parallel | 125 (91) |
Crossover | 11 (8) |
Other | 2 (1) |
Type of intervention | |
Drug | 137 (92) |
Placebo | 83 (60) |
Active drug | 36 (26) |
Usual care | 1 (1) |
Other | 7 (5) |
Education or lifestyle | 3 (2) |
Nutrition | 6 (4) |
Device | 2 (1) |
Duration of follow-up (median and range)b
| 24 (0–364) weeks |
Classification of trial outcomes
COMET taxonomy
Core area | Core domains | Trials including one or more outcome in core domain (n (%)) | Outcomes included in core domain (n (%)) | Trials including as a primary outcomea (n) |
---|---|---|---|---|
Death | Mortality/survival | 3 (2.2) | 3 (0.2) | 0 |
Physiological/clinical | Blood and lymphatic system outcomes | 9 (6.5) | 19 (1.3) | 1 |
Cardiac outcomes | 20 (14.5) | 56 (3.9) | 9 | |
Congenital, familial and genetic outcomes | 0(0) | 0 (0) | ||
Endocrine outcomes | 31(22.5) | 50 (3.5) | 7 | |
Ear and labyrinth outcomes | 0 (0) | 0 (0) | 0 | |
Eye outcomes | 2 (1.4) | 2 (0.1) | 0 | |
Gastrointestinal outcomes | 5 (3.6) | 20 (1.4) | 2 | |
General outcomes | 65 (47.1) | 146 (10.1) | 3 | |
Hepatobiliary outcomes | 12 (8.7) | 25 (1.7) | 3 | |
Immune system outcomes | 28 (20.3) | 73 (5.1) | 4 | |
Infection and infestation outcomes | 4 (2.9) | 8 (0.6) | 0 | |
Injury and poisoning outcomes | 0 (0) | 0 (0) | 0 | |
Metabolism and nutrition outcomes | 121 (87.7) | 582 (40.3) | 92 | |
Musculoskeletal and connective tissue outcomes | 2 (1.4) | 2 (0.1) | 1 | |
Outcomes relating to neoplasms: benign, malignant and unspecified (including cysts and polyps) | 0 (0) | 0 (0) | 0 | |
Nervous system outcomes | 6 (4.3) | 16 (1.1) | 2 | |
Pregnancy, puerperium and perinatal outcomes | 0 (0) | 0 (0) | 0 | |
Renal and urinary outcomes | 27 (19.6) | 76 (5.3) | 5 | |
Reproductive system and breast outcomes | 0 (0) | 0 (0) | 0 | |
Psychiatric outcomes | 2 (1.4) | 2 (0.1) | 0 | |
Respiratory, thoracic and mediastinal outcomes | 3 (2.2) | 11 (0.8) | 1 | |
Skin and subcutaneous tissue outcomes | 1 (0.7) | 1 (0.1) | 0 | |
Vascular outcomes | 51 (37) | 134 (9.3) | 13 | |
Physical functioning | 5 (3.6) | 7 (0.5) | 0 | |
Life impact | Social functioning | 5 (3.6) | 6 (0.4) | 0 |
Role functioning | 3 (2.2) | 6 (0.4) | 0 | |
Emotional functioning/wellbeing | 8 (5.8) | 28 (1.9) | 0 | |
Cognitive functioning | 2 (1.4) | 22 (1.5) | 0 | |
Global quality of life | 4 (2.9) | 5 (0.3) | 0 | |
Perceived health status | 4 (2.9) | 4 (0.3) | 0 | |
Delivery of care | 30 (21.7) | 60 (4.2) | 4 | |
Personal circumstance | 0 (0) | 0 (0) | 0 | |
Resource use | Economic | 4 (4) | 6 (0.4) | 0 |
Hospital | 3 (2.2) | 4 (0.3) | 0 | |
Need for intervention | 16 (11.6) | 24 (1.7) | 1 | |
Societal/carer burden | 0 (0) | 0 (0) | 0 | |
Adverse events | Adverse events/effects | 33 (23.9) | 46 (3.2) | 5 |
Use of patient-reported outcome measures
Diabetes satisfaction with treatment (DTSQ and DTSQc) | SF-36 | Diabetes distress scale | Summary of diabetes self-care activities | Diabetes self-care activities scale. | 8 item Morisky Medication Adherence Scale | Basic activities of daily living | Cognitive Instrumental Activities of Daily Living Scale (Cog-IADL) | Diabetes empowerment scale | Diabetes Quality of Life (DQOL) | EQ5-D | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) | Global Clinical Dementia Rating | HFS-11 worry scale | Hospital anxiety and depression | Hypoglycaemia patient questionnaire | International physical activity questionnaire | Mini Mental State Examination (MMSE) | Montreal Cognitive Assessment scale [MoCA] | Patient Health Questionnaire-2 | Subjective Memory and Cognitive Complaint (SMCC) | Well Being questionnaire Short Form (W-BQ12) | WHO-5 | PROMs measuring outcome (n) | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trials using PROMs (n) | 4 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||
Core domains | Outcomes measured by PROM | ||||||||||||||||||||||||
Gastrointestinal outcomes | Nausea/vomiting | X | 1 | ||||||||||||||||||||||
Fullness/early satiety | X | 1 | |||||||||||||||||||||||
Bloating | X | 1 | |||||||||||||||||||||||
General outcomes | Pain | X | X | 2 | |||||||||||||||||||||
General health | X | 1 | |||||||||||||||||||||||
Metabolism and nutrition outcomes | Symptomatic hypoglycaemia | X | 1 | ||||||||||||||||||||||
Asymptomatic hypoglycaemia | X | 1 | |||||||||||||||||||||||
Physical functioning | Mobility | X | 1 | ||||||||||||||||||||||
Physical functioning | X | 1 | |||||||||||||||||||||||
Energy/fatigue | X | X | 2 | ||||||||||||||||||||||
Physical activity | 1 | 1 | |||||||||||||||||||||||
Activities of daily living | X | X | 2 | ||||||||||||||||||||||
Usual activities | X | 1 | |||||||||||||||||||||||
Social functioning | Managing the psychosocial aspects of diabetes | 0 | |||||||||||||||||||||||
Quality of life – social/vocational concern | X | 1 | |||||||||||||||||||||||
Social functioning | X | X | 2 | ||||||||||||||||||||||
Quality of life – general interest | X | 1 | |||||||||||||||||||||||
Role functioning | Role limitations due to physical health | X | 1 | ||||||||||||||||||||||
Role limitations due to emotional problem | X | 1 | |||||||||||||||||||||||
Emotional functioning/wellbeing | Dissatisfaction and readiness to change | X | 1 | ||||||||||||||||||||||
Setting and achieving goals | X | 1 | |||||||||||||||||||||||
Emotional burden | X | 1 | |||||||||||||||||||||||
Regimen distress | X | 1 | |||||||||||||||||||||||
Interpersonal distress | X | 1 | |||||||||||||||||||||||
Physician distress | X | 1 | |||||||||||||||||||||||
Anxiety | X | X | 2 | ||||||||||||||||||||||
Depression | X | X | X | 3 | |||||||||||||||||||||
Worries about diabetes | X | 1 | |||||||||||||||||||||||
Emotional wellbeing | X | 1 | |||||||||||||||||||||||
Mood | X | 1 | |||||||||||||||||||||||
Vitality | X | 1 | |||||||||||||||||||||||
Negative wellbeing | X | 1 | |||||||||||||||||||||||
Positive wellbeing | X | 1 | |||||||||||||||||||||||
General well being | X | 1 | |||||||||||||||||||||||
Fear of hypoglycaemia – behaviour | X | 1 | |||||||||||||||||||||||
Fear of hypoglycaemia – worry | X | 1 | |||||||||||||||||||||||
Cognitive functioning | Orientation | X | X | X | 3 | ||||||||||||||||||||
Registration | X | 1 | |||||||||||||||||||||||
Attention and calculation | X | 1 | |||||||||||||||||||||||
Recall | X | 1 | |||||||||||||||||||||||
Language | X | X | 2 | ||||||||||||||||||||||
Attention and concentration | X | 1 | |||||||||||||||||||||||
Executive function | X | 1 | |||||||||||||||||||||||
Memory | X | X | 2 | ||||||||||||||||||||||
Visuo-constructional skills | X | 1 | |||||||||||||||||||||||
Conceptual thinking | X | 1 | |||||||||||||||||||||||
Calculations | X | 1 | |||||||||||||||||||||||
Judgement and problem solving | X | 1 | |||||||||||||||||||||||
Community affairs | X | 1 | |||||||||||||||||||||||
Home and hobbies | X | 1 | |||||||||||||||||||||||
Personal care | X | 1 | |||||||||||||||||||||||
Subjective memory | X | 1 | |||||||||||||||||||||||
Cognitive complaint | X | 1 | |||||||||||||||||||||||
Global quality of life | Quality of life – life satisfaction | X | 1 | ||||||||||||||||||||||
Quality of Life - diabetes impact | X | 1 | |||||||||||||||||||||||
Perceived health status | Perceived blood glucose control | X | 1 | ||||||||||||||||||||||
Delivery of care | Self-care activities – general diet | X | X | 2 | |||||||||||||||||||||
Self-care activities – specific diet | X | X | 2 | ||||||||||||||||||||||
Self-care activities – medication taking | X | 1 | |||||||||||||||||||||||
Self-care activities – blood glucose testing | X | X | 2 | ||||||||||||||||||||||
Self-care activities – exercise | X | X | 2 | ||||||||||||||||||||||
Self-care activities – foot care | X | X | 2 | ||||||||||||||||||||||
Self-care activities – smoking | X | X | 2 | ||||||||||||||||||||||
Self-care – unspecified | X | 1 | |||||||||||||||||||||||
Satisfaction with treatment | X | 1 | |||||||||||||||||||||||
Patient knowledge of treatment for hypoglycaemia | X | 1 | |||||||||||||||||||||||
Medication adherence | X | 1 | |||||||||||||||||||||||
Patient knowledge driving and hypoglycaemia | X | 1 |