Pancreatogenic Type 3C Diabetes MellitusNCT05550480
Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes
A study testing Continuous glucose monitoring in people with Pancreatogenic Type 3C Diabetes Mellitus, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatogenic Type 3C Diabetes Mellitus
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Sep 2022to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Continuous glucose monitoring
- Keywords
- Chronic pancreatitis, Pancreatic Diseases, Digestive System Diseases, Diabetes, Continuous Glucose Monitoring
- Medical subject headings
- Pancreatitis, Chronic, Pancreatic Diseases, Digestive System Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Also called CGM
Continuous glucose monitoring for 50 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
The difference between CGM and self-monitoring of blood glucose in time below range (glucose value < 3.9 mmol/L) measured by CGM.
Measured: 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)
The difference between CGM and self-monitoring of blood glucose in time below range (glucose value 3.0-3.8 mmol/L) measured by CGM.
Measured: 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)
The difference between CGM and self-monitoring of blood glucose in time above range (glucose value >10.0 mmol/L) measured by CGM.
Measured: 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)
The difference between CGM and self-monitoring of blood glucose in time above range (glucose value 10.1-13.9 mmol/L) measured by CGM.
Measured: 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 >13.9 mmol/L, hyperglycaemia level 2)
The difference between CGM and self-monitoring of blood glucose in time above range (glucose value >13.9 mmol/L) measured by CGM.
Measured: 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.
Mean glucose (mmol/L)
The difference between CGM and self-monitoring of blood glucose in mean glucose (mmol/L) measured by CGM.
Measured: The last 20 ±2 days of each study period
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.
Measured: 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.
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.
Measured: 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.
Insulin dose (unit)
The difference in the mean insulin dose between CGM and self-monitoring of blood glucose.
Measured: The last 20 ±2 days of each study period
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.
Measured: At the end of each study period (day 70 ±2 and 140 ±2).
Patient global impression of change score (PGIC)
Difference between CGM and self-monitoring of blood glucose in Patient global impression of change score (PGIC). The PGIC is a self-reported measure used to assess a patient's overall perception of improvement or change in their condition over time. It uses a 7-point scale, ranging from "very much improved" to "very much worse". A score ≤3 means that the condition has improved.
Measured: At the end of each study period (day 70 ±2 and 140 ±2).
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.
Measured: At the end of each study period (day 70 ±2 and 140 ±2).
Standard deviation (mmol/L)
The difference between CGM and self-monitoring of blood glucose in standard deviation of mean glucose (mmol/L) measured by CGM.
Measured: 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.
Coefficient of variance (%)
The difference between CGM and self-monitoring of blood glucose in coefficient of variance of mean glucose (mmol/L) measured by CGM.
Measured: 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.
HbA1c (mmol/L)
The difference between CGM and self-monitoring of blood glucose in HbA1c mmol/L.
Measured: At the end of each study period (day 70 ±2 and 140 ±2).
HbA1c (percentage)
The difference between CGM and self-monitoring of blood glucose in HbA1c (percentage).
Measured: At the end of each study period (day 70 ±2 and 140 ±2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start8 Sep 2022
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatogenic Type 3C Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soren Schou Olesen, Aalborg University Hospital
- Investigators
- Søren S Olesen, Professor, Principal investigator, Mech-Sense, Department of Gastroenterology, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550480
- Sponsor's protocol ID
- N-20210064
- Other IDs
- N-20210064
- Status last verified
- Oct 2024
- First submitted
- 15 Sep 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes
- ClinicalTrials.gov ID
- NCT05550480
- Acronym / sponsor ID
- N-20210064
- Conditions
- Pancreatogenic Type 3C Diabetes Mellitus
- Keywords
- Chronic pancreatitis, Pancreatic Diseases, Digestive System Diseases, Diabetes, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | Experimental | Device: Continuous glucose monitoringParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringAlso: CGMContinuous glucose monitoring for 50 days | Device | Continuous glucose monitoring |
Primary outcome
Time spent with glucose value <3.0 mmol/l (level 2 hypoglycemia)
Time frame: 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.
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.
17 secondary outcomes
Time in range (glucose value 3.9 - 10.0 mmol/l)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 >13.9 mmol/L, hyperglycaemia level 2)
Time frame: 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.
Mean glucose (mmol/L)
Time frame: The last 20 ±2 days of each study period
Mean amplitude of glycemic excursions [MAGE]
Time frame: 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.
Continuous overall net glycemic action [CONGA]
Time frame: 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.
Insulin dose (unit)
Time frame: The last 20 ±2 days of each study period
Quality of life (EORTC QLQ-C30)
Time frame: At the end of each study period (day 70 ±2 and 140 ±2).
Patient global impression of change score (PGIC)
Time frame: At the end of each study period (day 70 ±2 and 140 ±2).
Hypoglycemia awareness
Time frame: At the end of each study period (day 70 ±2 and 140 ±2).
Standard deviation (mmol/L)
Time frame: 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.
Coefficient of variance (%)
Time frame: 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.
HbA1c (mmol/L)
Time frame: At the end of each study period (day 70 ±2 and 140 ±2).
HbA1c (percentage)
Time frame: At the end of each study period (day 70 ±2 and 140 ±2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren S Olesen, Professor principal investigator
Mech-Sense, Department of Gastroenterology, Aalborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring in people with Pancreatogenic Type 3C Diabetes Mellitus, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent with glucose value <3.0 mmol/l (level 2 hypoglycemia) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.