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

Primary Purpose

Pancreatogenic Type 3C Diabetes Mellitus

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Continuous glucose monitoring

About this trial

This is an interventional treatment trial for Pancreatogenic Type 3C Diabetes Mellitus focused on measuring Chronic pancreatitis, Pancreatic Diseases, Digestive System Diseases, Diabetes, Continuous Glucose Monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent before any study specific procedures
Able to read and understand Danish
Male or female age ≥ 18 ≤ 80 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
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

Sites / Locations

Department of Gastroenterology, Aalborg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous glucose monitoring

Self-monitoring of blood glucose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The difference between CGM and self-monitoring of blood glucose in time in range (glucose value 3.9 - 10.0 mmol/L) measured by CGM.

Time below range (glucose <3.9 mmol/L)

The difference between CGM and self-monitoring of blood glucose in time below range (glucose value < 3.9 mmol/L) measured by CGM.

Time above range (glucose >10.0 mmol/L)

The difference between CGM and self-monitoring of blood glucose in time above range (glucose value >10.0 mmol/L) measured by CGM.

Mean glucose (mmol/L)

The difference between CGM and self-monitoring of blood glucose in mean glucose (mmol/L) measured by CGM.

Mean amplitude of glycemic excursions [MAGE]

The difference between CGM and self-monitoring of blood glucose in mean amplitude of glycemic excursions [MAGE] measured by CGM.

Continuous overall net glycemic action [CONGA]

The difference between CGM and self-monitoring of blood glucose in continuous overall net glycemic action [CONGA] measured by CGM.

Insulin dose (unit)

The difference in the mean insulin dose between CGM and self-monitoring of blood glucose.

Quality of life (EORTC QLQ-C30)

Difference between CGM and self-monitoring of blood glucose in quality of life assessed by EORTC QLQ-C30 questionnaire. The questionnaire has been validated for assessment of quality of life in patients with chronic pancreatitis and is composed of single-item measures and multi-item scales with scores ranging from 0 to 100 after linear transformation of the raw score. A high score for a functional scale represents a high level of functioning, as does a high score for the global health status, while a high score for the symptom items represents a high level of symptomatology.

Hypoglycemia awareness

The difference between CGM and self-monitoring of blood glucose in hypoglycemia awareness assessed by the Clarke Hypoglycemia Awareness Survey. It comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to, hypoglycemia. A score of four or more implies impaired awareness of hypoglycemia.

Full Information

NCT ID

NCT05550480

First Posted

September 15, 2022

Last Updated

September 19, 2022

Sponsor

Aalborg University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05550480

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2022 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatogenic Type 3C Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continuous glucose monitoring

Arm Type

Experimental

Arm Description

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.

Arm Title

Self-monitoring of blood glucose

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Continuous glucose monitoring

Other Intervention Name(s)

CGM

Intervention Description

Continuous glucose monitoring for 50 days

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

The observation period starts on day 50 after the start of the study period and ends after 20 days (day 70 - end of the study period)

Secondary Outcome Measure Information:

Title

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

Description

The difference between CGM and self-monitoring of blood glucose in time in range (glucose value 3.9 - 10.0 mmol/L) measured by CGM.

Time Frame

The observation period starts on day 50 after the start of the study period and ends after 20 days (day 70 - end of the study period)

Title

Time below range (glucose <3.9 mmol/L)

Description

The difference between CGM and self-monitoring of blood glucose in time below range (glucose value < 3.9 mmol/L) measured by CGM.

Time Frame

The observation period starts on day 50 after the start of the study period and ends after 20 days (day 70 - end of the study period)

Title

Time above range (glucose >10.0 mmol/L)

Description

The difference between CGM and self-monitoring of blood glucose in time above range (glucose value >10.0 mmol/L) measured by CGM.

Time Frame

The observation period starts on day 50 after the start of the study period and ends after 20 days (day 70 - end of the study period)

Title

Mean glucose (mmol/L)

Description

The difference between CGM and self-monitoring of blood glucose in mean glucose (mmol/L) measured by CGM.

Time Frame

The last 20 days of each study period

Title

Mean amplitude of glycemic excursions [MAGE]

Description

The difference between CGM and self-monitoring of blood glucose in mean amplitude of glycemic excursions [MAGE] measured by CGM.

Time Frame

The observation period starts on day 50 after the start of the study period and ends after 20 days (day 70 - end of the study period)

Title

Continuous overall net glycemic action [CONGA]

Description

The difference between CGM and self-monitoring of blood glucose in continuous overall net glycemic action [CONGA] measured by CGM.

Time Frame

The observation period starts on day 50 after the start of the study period and ends after 20 days (day 70 - end of the study period)

Title

Insulin dose (unit)

Description

The difference in the mean insulin dose between CGM and self-monitoring of blood glucose.

Time Frame

From baseline till the end of each study period (70 days)

Title

Quality of life (EORTC QLQ-C30)

Description

Time Frame

At baseline and the end of each study period (day 70).

Title

Hypoglycemia awareness

Description

Time Frame

At baseline and the end of each study period (day 70).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent before any study specific procedures Able to read and understand Danish Male or female age ≥ 18 ≤ 80 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Line Davidsen, MD

Phone

97663520

Ext

+45

l.davidsen@rn.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Søren S Olesen, Professor

Organizational Affiliation

Mech-Sense, Department of Gastroenterology, Aalborg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gastroenterology, Aalborg Hospital

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Søren S Olesen, Professor

Phone

97663510

Ext

+45

soso@rn.dk

First Name & Middle Initial & Last Name & Degree

Line Davidsen, MD

Phone

97663520

Ext

+45

l.davidsen@rn.dk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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