Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes

NCT05550480 | Completed

• 1 other identifier: N-20210064
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatogenic Type 3C Diabetes Mellitus

Keywords

Chronic pancreatitis; Pancreatic Diseases; Digestive System Diseases; Diabetes; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Time spent with glucose value <3.0 mmol/l (level 2 hypoglycemia)

  The difference between CGM and self-monitoring of blood glucose in time spent with glucose value \<3.0 mmol/l (level 2 hypoglycemia) measured by CGM.

  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 (17)

• Time in range (glucose value 3.9 - 10.0 mmol/l)

  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.

• Time below range (glucose <3.9 mmol/L)

  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.

• Time below range (glucose 3.0-3.8 mmol/L, hypoglycaemia level 1)

  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.

• Time above range (glucose >10.0 mmol/L)

  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.

• Time above range (glucose 10.1-13.9 mmol/L, hyperglycaemia level 1)

  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.

Study Arms (2)

Continuous glucose monitoring

EXPERIMENTAL

Participants will monitor their glucose levels using CGM with access to interstitial glucose levels continuously throughout the day. Each study period is preceded by 20 days of masked CGM assessment.

Device: Continuous glucose monitoring

Self-monitoring of blood glucose

NO INTERVENTION

Participants will monitor their blood glucose levels using a glucometer and a capillary blood sample from finger-pricking. Participants will in addition use masked CGM for the last 20 days of the study period to monitor glucose levels for comparison. Each study period is preceded by 20 days of masked CGM assessment.

Interventions

Continuous glucose monitoring DEVICE

Continuous glucose monitoring for 50 days

Also known as: CGM

Continuous glucose monitoring

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known or suspected abdominal cancer (incl. intestine, pancreas, and the hepato-biliary system)
• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Department of Gastroenterology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatic Diseases; Digestive System Diseases; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Søren S Olesen, Professor

  Mech-Sense, Department of Gastroenterology, Aalborg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, MD, PhD

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 22, 2022
• Study Start: September 8, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)