Clinical trial NCT05550480: Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes
Official title: Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatogenic Type 3C Diabetes Mellitus
Keywords: Chronic pancreatitis
Pancreatic Diseases
Digestive System Diseases
Diabetes
Continuous Glucose Monitoring
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The use of CGM in people with type 1 or type 2 diabetes receiving multiple daily insulin injections improves glycemic control and reduces time spent in hypoglycemia compared to self-monitoring. These beneficial effects of CGM are likely also present in people with pancreatogenic diabetes but have only been sparsely investigated.

In this study, the investigators, therefore, aim to investigate the effects of CGM (compared to self-monitoring) on hypoglycemia and glycemic control in patients with pancreatogenic diabetes. Patients with chronic pancreatitis and insulin-treated diabetes will be randomized 1:1 to receive 50 days of CGM followed by 50 days of self-monitoring or vice versa. Each study period is preceded by 20 days of masked CGM assessment, which also serves as the washout period between the two study periods. Furthermore, the self-monitoring group will use masked CGM for the last 20 days of the study period to monitor glucose levels for comparison with the unmasked CGM period. Thus, each study period lasts a total of 70 days.

The investigators hypothesize that the use of CGM vs self-monitoring of blood glucose in patients with pancreatogenic diabetes will lead to decreased time spent with a glucose value \<3.0 mmol/l and increased time in glycemic range.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Time in range (glucose value 3.9 - 10.0 mmol/l)
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.
measure: Time below range (glucose <3.9 mmol/L)
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.
measure: Time below range (glucose 3.0-3.8 mmol/L, hypoglycaemia level 1)
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.
measure: Time above range (glucose >10.0 mmol/L)
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.
measure: Time above range (glucose 10.1-13.9 mmol/L, hyperglycaemia level 1)
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.
measure: Time above range (glucose >13.9 mmol/L, hyperglycaemia level 2)
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.
measure: Mean glucose (mmol/L)
timeFrame: The last 20 ±2 days of each study period
measure: Mean amplitude of glycemic excursions [MAGE]
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.
measure: Continuous overall net glycemic action [CONGA]
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.
measure: Insulin dose (unit)
timeFrame: The last 20 ±2 days of each study period
measure: Quality of life (EORTC QLQ-C30)
timeFrame: At the end of each study period (day 70 ±2 and 140 ±2).
measure: Patient global impression of change score (PGIC)
timeFrame: At the end of each study period (day 70 ±2 and 140 ±2).
measure: Hypoglycemia awareness
timeFrame: At the end of each study period (day 70 ±2 and 140 ±2).
measure: Standard deviation (mmol/L)
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.
measure: Coefficient of variance (%)
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.
measure: HbA1c (mmol/L)
timeFrame: At the end of each study period (day 70 ±2 and 140 ±2).
measure: HbA1c (percentage)
timeFrame: At the end of each study period (day 70 ±2 and 140 ±2).
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Gastroenterology, Aalborg Hospital
Study officials:
affiliation: Mech-Sense, Department of Gastroenterology, Aalborg Hospital
name: Søren S Olesen, Professor
role: PRINCIPAL_INVESTIGATOR
References: