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

NCT ID: NCT05550480

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2024-06-05

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.

Conditions

Pancreatogenic Type 3C Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous glucose monitoring

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.

Group Type: EXPERIMENTAL

Continuous glucose monitoring

Intervention Type: DEVICE

Continuous glucose monitoring for 50 days

Self-monitoring of blood glucose

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous glucose monitoring

Continuous glucose monitoring for 50 days

Intervention Type: DEVICE

Other Intervention Names

CGM

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soren Schou Olesen

Professor, Chief Physician, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Søren S Olesen, Professor

Role: PRINCIPAL_INVESTIGATOR

Mech-Sense, Department of Gastroenterology, Aalborg Hospital

Locations

Department of Gastroenterology, Aalborg Hospital

Aalborg, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

N-20210064

Identifier Type: OTHER

Identifier Source: secondary_id

N-20210064

Identifier Type: -

Identifier Source: org_study_id