Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes (NCT05550480) | Clinical Trial Compass
CompletedNot Applicable
Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes
Denmark30 participantsStarted 2022-09-08
Plain-language summary
This study will investigate the effect of continuous glucose monitoring (CGM) (compared to self-monitoring) on hypoglycemia and glycemic control in patients with insulin-treated pancreatogenic diabetes.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent before any study specific procedures
* Able to read and understand Danish
* Male or female age ≥ 18 ≤ 85 years
* A definitive diagnosis of chronic pancreatitis based on the M-ANNHEIM criteria
* A diagnosis of insulin treated pancreatogenic diabetes based on the World Health Organization criteria for diabetes (HbA1c ≥6.5 % (48 mmol/mol) and/or fasting plasma glucose ≥126 mg/dl (7.0 mmol/l)) \>3 months after diagnosis of pancreatitis
Exclusion Criteria:
* Known or suspected abdominal cancer (incl. intestine, pancreas, and the hepato-biliary system)
* Severe pre-existing comorbidities (assessed by investigator upon inclusion)
* Attack of acute on chronic pancreatitis requiring admission within four weeks prior to inclusion
* Use of glucocorticoid medications within four weeks prior to inclusion, with the exception of inhaled glucocorticoids in the treatment of chronic pulmonary diseases.
* Presence of autoimmune antibodies suggestive of type 1 diabetes
* Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure)
* Prior gastric surgery or vagotomy
* Autoimmune pancreatitis
What they're measuring
1
Time spent with glucose value <3.0 mmol/l (level 2 hypoglycemia)
Timeframe: In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.