Clinical trials: Fear of Hypoglycemia
Diabetes Mellitus, Type 1
Effects of Structured Group Education on Quality of Life and Glycemic Control in Type 1 Diabetes
Patients with type 1 diabetes aged 15-65 years without major complications will be randomized either to usual care or to a structured group education program, with 6 four-hour weekly interactive sessions devoted to diabetes…
- Trial name
- NCT02443532
- Testing
- Structured group education, Individual education
- Volunteers
- 72 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Type 1 Diabetes Mellitus (T1DM), Diabetes Distress
GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes
Type 1 diabetes diagnosed in childhood requires rapid acquisition of complex self-management skills while children and caregivers are also adapting emotionally and socially to a chronic condition.
- Conditions
- Type 1 Diabetes Mellitus (T1DM), Diabetes Distress, Hypoglycemia (Diabetic), Family Conflict
- Trial name
- GlycoQuest (NCT07726680)
- Testing
- GlycoQuest Digital Therapeutic, Enhanced Digital Psychoeducation
- Where
- Pakistan
- Volunteers
- 110 people
- Sponsor
- Shifa International Hospital
Diabetes Mellitus, Type 1
Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)
Primary objective: AT.LANTUS main study* To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemia.(*Target Number of patients for the main study:2346) HALT Sub-study** To…
- Trial name
- AT-LANTUS (NCT00390728)
- Testing
- Insulin Glargine
- Volunteers
- 2,346 people
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus
A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life.
- Trial name
- CBT (NCT03549104)
- Testing
- Fear Reduction Intervention, Attention Control
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Illinois at Chicago
Type1diabetes, Fear of Hypoglycemia
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot…
- Trial name
- NCT03039933
- Testing
- Fear of Hypoglycemia, Treatment As Usual
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of Colorado, Denver
Diabetes Mellitus Type 1, Glucose Metabolism Disorder
Real-life Follow-up of the Physical Activity in Type 1 Diabetes Participants Equipped With an Insulin Pump With Hybrid Closed Loop
This is a non-interventional, prospective, multi-site study conducted in France among adults with type 1 diabetes mellitus using automated insulin delivery (AID) systems and engaging in at least two exercise sessions per week…
- Conditions
- Diabetes Mellitus Type 1, Glucose Metabolism Disorder, Glycemic Control for Diabetes Mellitus, Fear of Hypoglycemia
- Trial name
- RAPPID (NCT07015970)
- Testing
- No Intervention: Observational Cohort
- Where
- 4 sites in France
- Volunteers
- 87 people
- Sponsor
- ISIS Diabete Service
Type2diabetes, Hypoglycemia
The Effectiveness of Multimedia Education on Hypoglycemic Management.
The first phase of the research was to develop tools, including scales and multimedia, and the second phase was to carry out multimedia hypoglycemia education intervention measures.
- Trial name
- NCT06516705
- Testing
- Hypoglycemia education
- Where
- Taiwan
- Volunteers
- 83 people
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Type 2 Diabetes Mellitus, Fear of Hypoglycemia
Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study
The purpose of this study was to construct a Fear of Hypoglycemia(FoH) intervention program for type 2 diabetic patients based on the Behaviour Change Wheel (BCW) theory and to investigate the feasibility, acceptability, and…
- Conditions
- Type 2 Diabetes Mellitus, Fear of Hypoglycemia, Health Education, Impaired Awareness of Hypoglycemia
- Trial name
- NCT06197360
- Testing
- Based on BCW Theory of Health Education, General diabetes health education
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Yangzhou University
Type 1 Diabetes Mellitus
Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
Investigators developed REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in Parents), an innovative video-based telemedicine intervention.
- Trial name
- REDCHiP (NCT03914547)
- Testing
- REDCHiP, ATTN
- Where
- 2 sites in United States
- Volunteers
- 394 people
- Sponsor
- Nemours Children's Clinic
Depression
Assessment of Psychological State of Mothers of Diabetic Children Aged 5 and Under (in Terms of Depression, Stress, Coping , Anxiety, Fear of Hypoglycemia) and Influencing Factors of This Psychological State
The incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children.
- Trial name
- PSY-DIA-MUM (NCT02862626)
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Diabetes (DM), Diabetes Mellitus
Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin…
- Conditions
- Diabetes (DM), Diabetes Mellitus, Diabetes Mellitus Type 2, Diabetes Mellitus Type 1
- Trial name
- NCT07814508
- Testing
- SmartGuide CGM with Predictive Features
- Where
- Germany
- Volunteers
- 89 people
- Sponsor
- FIDAM RDC
Type 1 Diabetes Mellitus
Hypoglycemia Fear Affect Autonomic Function, Physical Activity, and Exercise Capacity in Type I Diabetes
This cross-sectional study aims to investigate whether fear of hypoglycemia affects autonomic function, physical activity levels, and exercise capacity in children and adolescents with T1DM.
- Trial name
- HypoFear-T1DM (NCT07527676)
- Testing
- No intervention (observational study)
- Where
- Turkey (Türkiye)
- Volunteers
- 67 people
- Sponsor
- Ordu University
Type1diabetes
HIT on Hypoglycaemic Risk in T1D
There is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. However, many people with type 1 diabetes do not exercise regularly.
- Trial name
- NCT05044442
- Testing
- moderate intensity continous training, high intensity interval training
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Liverpool John Moores University
Diabetes (DM), Diabete Mellitus
Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups
Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes.
- Conditions
- Diabetes (DM), Diabete Mellitus, Diabete Type 1, Diabete Type 2
- Trial name
- TwinPeaks (NCT07212075)
- Where
- 3 sites in Germany
- Volunteers
- 1,809 people
- Sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
Parents
Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes
Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.
- Trial name
- REDCHiP (NCT03879642)
- Testing
- REDCHiP
- Volunteers
- 43 people
- Sponsor
- University of Kansas Medical Center
Nurse's Role, Diabetes Mellitus
Nurse Coaching the Effect of on Glycemic Control, Fear of Hypoglycemia and Risk Perception in Adults With Type 1 Diabetes.
Because of the unforeseen rate of increase in case numbers, the high rates of mortality and morbidity, and the increased socio economic load it causes, diabetes has become the most discussed chronic and widespread metabolic…
- Conditions
- Nurse's Role, Diabetes Mellitus, Hypoglycemia
- Trial name
- NCT05870280
- Testing
- nurse coaching
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Tuğba Bilgehan
Diabetes Type 1
French Version of the Scales of Fear of Hypoglycaemia in Children With Type 1 Diabetes and Their Parents
Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence…
- Trial name
- FHS (NCT03529188)
- Where
- 3 sites in France
- Volunteers
- 194 people
- Sponsor
- University Hospital, Brest
Type1diabetes
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
This study is being conducted to determine the feasibility of a cognitive behavioral therapy intervention to reduce fear of hypoglycemia and improve glucose levels in young adults with type 1 diabetes.
- Trial name
- FREE (NCT03165786)
- Testing
- FREE
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Illinois at Chicago
Type 1 Diabetes
Fear of Hypoglycemia and Glycemic Variability
Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the…
- Trial name
- VARDIA (NCT02790060)
- Where
- 9 sites in France
- Volunteers
- 600 people
- Sponsor
- Poitiers University Hospital
Diabetes Mellitus, Type 1
The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes
The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes.
- Trial name
- PENELOPE (NCT06414824)
- Testing
- Intermittently Scanned Continuous Glucose Monitoring, Standard Blood Glucose Monitoring
- Where
- 4 sites in Poland
- Volunteers
- 28 people
- Sponsor
- Jagiellonian University