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Hypoglycemia clinical trials

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NCT ID: NCT02605369 Completed - Preterm Birth Clinical Trials

SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.

NCT ID: NCT02590016 Recruiting - Clinical trials for Gestational Diabetes

Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial

Start date: September 2015
Phase: Phase 4
Study type: Interventional

Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour. In the observational group, blood glucose level during labour will be monitored and insulin-glucose-infusion is started only if needed. The hypothesis is that there will not be a difference in rate of hypoglycemia between the two groups and that the proportion of observational group participants that need infusion is low.

NCT ID: NCT02586831 Withdrawn - Diabetes Mellitus Clinical Trials

Diabetes Islet Preservation Immune Treatment

DIPIT
Start date: January 2025
Phase: Phase 1/Phase 2
Study type: Interventional

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

NCT ID: NCT02583776 Completed - Clinical trials for Infant, Very Low Birth Weight

Continuous Glucose Monitoring and Preterm Infants

CGM&VLBWI
Start date: October 2015
Phase: Phase 4
Study type: Interventional

Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes in preterm newborns. The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI. It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within 48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4 Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be evaluated with the validated Premature Infant Pain Profile (PIPP) scale. The estimated numerosity is 50 patients (25 for each arm).

NCT ID: NCT02578498 Completed - Type 1 Diabetes Clinical Trials

Glucagon Efficiency After High and Low Carbohydrate Diet

HiLoCarb
Start date: October 2015
Phase: Phase 4
Study type: Interventional

No studies have investigated if the dietary composition of carbohydrate influences the glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further, the recommended diet composition to patients with type 1 diabetes has not been thoroughly validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated. The purpose of this study is to determine, whether diet composition of carbohydrate affects the glycogen stores in the liver and affects the glucose response of glucagon during hypoglycaemia. HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of low-dose glucagon is not associated with diet carbohydrate content. AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet influence the glycaemic response of low-dose glucagon in patients with insulin pump treated type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose excursions. DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After participants have given an informed consent, they will go through four steps: 1) screening visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study visit and 4) second meal intervention for one week finalizing with another study visit.

NCT ID: NCT02550145 Recruiting - Hypoglycemia Clinical Trials

Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

Start date: February 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.

NCT ID: NCT02533219 No longer available - Clinical trials for Congenital Hyperinsulinism

Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia

[18F]-DOPA
Start date: n/a
Phase:
Study type: Expanded Access

The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.

NCT ID: NCT02527993 Completed - Obesity Clinical Trials

Treatment of Hypoglycemia Following Gastric Bypass Surgery

Start date: October 2015
Phase: Phase 4
Study type: Interventional

Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. The surgery results in significant and sustained weight loss and has a beneficial effect on blood glucose regulation. However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia years after the operation, with symptoms varying from mild dizziness to confusion, loss of consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to an oral glucose load are believed to play a role in the syndrome, which is not yet fully understood. There are no current treatment guidelines beside dietary recommendations. The purpose of this study is to compare different pharmacological treatments on daily blood glucose variations as well as postprandial hormonal and autonomous changes in subjects with symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.

NCT ID: NCT02523222 Completed - Hypoglycemia Clinical Trials

Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

Start date: July 2016
Phase: N/A
Study type: Interventional

This will be a quasi-experimental study comparing blood glucose values 30 minutes after feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal hypoglycemia.

NCT ID: NCT02518022 Withdrawn - Clinical trials for Type 1 Diabetes Mellitus

How to be Safe With Alcoholic Drinks in Diabetes

BEER
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin Bolus.