Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-05
Brief Title:
Closed Loop and Education for Hypoglycemia Awareness Restoration
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Closed Loop and Education for Hypoglycemia Awareness Restoration CLEAR Conducted by the Impaired Awareness of Hypoglycemia Consortium IAHC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEAR
Brief Summary:
The purpose of the CLEAR study is to determine the effect on counterregulatory responses CRR of intervening by attempting to strictly avoid hypoglycemia to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes T1D who have impaired awareness of hypoglycemia IAH IAH affects 20-25 of adults with T1D and rises with increasing duration of T1D
Detailed Description:
Individuals with IAH exhibit blunted symptomatic and CR hormonal responses to hypoglycemia and as such have an impaired ability to respond to hypoglycemia Thus rates of severe hypoglycemia are up to 6-fold greater in those affected Intensive management of T1D is necessary in preventing long-term complications but can be complicated by recurrent episodes of hypoglycemia which lead to and sustain the CRR deficits of IAH Technologies such as continuous glucose monitoring CGM and hybrid closed-loop HCL systems can reduce severe hypoglycemia and also may reduce IAH but the ability of technology to reverse impaired CRR as assessed with experimental hypoglycemia clamp remains unclear Behavioral and psycho-educational interventions targeting knowledgeskills gaps as well as particular cognitions and behaviors driving recurrent hypoglycemia can also reduce severe hypoglycemia and improve awareness No studies have compared technology with such behavioral interventions in terms of assessing their impact on IAH or the CRR as a primary outcome Unanswered questions include the degree of reduction in hypoglycemia required to restore awareness Furthermore participants may respond to different interventions according to their characteristics For example it remains unclear whether older individuals benefit from such interventions since they usually are excluded from studies Therefore there is an urgent need to determine effective interventions that can reverse IAH in a large representative population of adults with T1D and IAH The investigators propose to study the effect of specific interventions aimed at restoring
the CRR tested via an experimental hypoglycemia clamp procedure
hypoglycemia awareness self-reported via the Towler Questionnaire during the experimental hypoglycemia clamp procedure
The study will use a Sequential Multiple Assignment Randomized Trial SMART design At baseline all participants who are HCL naïve will be randomized to HCL or Usual Care UC plus brief education My HypoCOMPaSS with a follow-up of two years UC will consist of real-time continuous glucose monitoring CGM and insulin delivery via pump or multiple daily injections Participants who fail to increase their CRR at 12 months will be randomized or assigned to a second intervention consisting of a small-group educational program focusing on motivations and unhelpful cognitions acting as barriers to hypoglycemia avoidance HARPdoc At baseline all participants who are HCL non-naïve will be randomized to optimized HCL or HCL plus My HypoCOMPaSS those with non-responsive CRR at 12 months will be randomized to either continue HCL on the basis they need a longer period to reverse impaired CRR and total symptomatic responses or to the HARPdoc intervention Participants randomized to an HCL device are expected to wear the device continually as well as a CGM The My HypoCOMPaSS education requires 4-5 hours of training whereas the HARPdoc education requires four training sessions of seven hours each during weeks 123 and 6
The specific aims and hypotheses are as follows
Aim 1 To determine the effect on CRR epinephrine increase 125 pgml over baseline and total symptom responses Towler Questionnaire increase 20 over baseline during a hyperinsulinemic-hypoglycemic clamp procedure glucose 50 mgdl after 12 months of HCL versus Usual Care plus My HypoCOMPaSS Educational Intervention among adults with T1D and IAH who have never used HCL therapy previously
Hypothesis 1 At 12 months those allocated to Usual Care plus My HypoCOMPaSS will be more likely to have improved CRR and total symptomatic responses than those allocated to HCL
Aim 2 To determine the effect on CRR and total symptom responses at 12 months of HCL plus My HypoCOMPaSS versus HCL alone among adults with T1D and IAH who are currently using HCL therapy prior to entering the study
Hypothesis 2 At 12 months those allocated to HCL plus My HypoCOMPaSS will be more likely to have improved hypoglycemic awareness and improved CRR than those using HCL alone
Aim 3 To determine the durability of effect over 24 months of the intervention that improves CRR at 12 months among adults with type 1 diabetes and IAH at baseline
Hypothesis 3 At 24 months CRR will improve further among those who had restored CRR at 12 months
Aim 4 To determine the effect on hypoglycemic awareness Towler Questionnaire increase 20 over baseline and CRR epinephrine increase 125 pgml over baseline during a hyperinsulinemic hypoglycemic clamp procedure at 24 months of an in-depth educational program HARPdoc initiated throughout months 12-24 among adults with T1D and IAH at baseline for whom the intervention allocated at baseline did not restore CRR at 12 months
Hypothesis 4 At 24 months those allocated to HARPdoc for months 12-24 months will be more likely to have improved hypoglycemic awareness and CRR than those who continue with the therapy allocated at baseline
the CRR tested via an experimental hypoglycemia clamp procedure
hypoglycemia awareness self-reported via the Towler Questionnaire during the experimental hypoglycemia clamp procedure
The study will use a Sequential Multiple Assignment Randomized Trial SMART design At baseline all participants who are HCL naïve will be randomized to HCL or Usual Care UC plus brief education My HypoCOMPaSS with a follow-up of two years UC will consist of real-time continuous glucose monitoring CGM and insulin delivery via pump or multiple daily injections Participants who fail to increase their CRR at 12 months will be randomized or assigned to a second intervention consisting of a small-group educational program focusing on motivations and unhelpful cognitions acting as barriers to hypoglycemia avoidance HARPdoc At baseline all participants who are HCL non-naïve will be randomized to optimized HCL or HCL plus My HypoCOMPaSS those with non-responsive CRR at 12 months will be randomized to either continue HCL on the basis they need a longer period to reverse impaired CRR and total symptomatic responses or to the HARPdoc intervention Participants randomized to an HCL device are expected to wear the device continually as well as a CGM The My HypoCOMPaSS education requires 4-5 hours of training whereas the HARPdoc education requires four training sessions of seven hours each during weeks 123 and 6
The specific aims and hypotheses are as follows
Aim 1 To determine the effect on CRR epinephrine increase 125 pgml over baseline and total symptom responses Towler Questionnaire increase 20 over baseline during a hyperinsulinemic-hypoglycemic clamp procedure glucose 50 mgdl after 12 months of HCL versus Usual Care plus My HypoCOMPaSS Educational Intervention among adults with T1D and IAH who have never used HCL therapy previously
Hypothesis 1 At 12 months those allocated to Usual Care plus My HypoCOMPaSS will be more likely to have improved CRR and total symptomatic responses than those allocated to HCL
Aim 2 To determine the effect on CRR and total symptom responses at 12 months of HCL plus My HypoCOMPaSS versus HCL alone among adults with T1D and IAH who are currently using HCL therapy prior to entering the study
Hypothesis 2 At 12 months those allocated to HCL plus My HypoCOMPaSS will be more likely to have improved hypoglycemic awareness and improved CRR than those using HCL alone
Aim 3 To determine the durability of effect over 24 months of the intervention that improves CRR at 12 months among adults with type 1 diabetes and IAH at baseline
Hypothesis 3 At 24 months CRR will improve further among those who had restored CRR at 12 months
Aim 4 To determine the effect on hypoglycemic awareness Towler Questionnaire increase 20 over baseline and CRR epinephrine increase 125 pgml over baseline during a hyperinsulinemic hypoglycemic clamp procedure at 24 months of an in-depth educational program HARPdoc initiated throughout months 12-24 among adults with T1D and IAH at baseline for whom the intervention allocated at baseline did not restore CRR at 12 months
Hypothesis 4 At 24 months those allocated to HARPdoc for months 12-24 months will be more likely to have improved hypoglycemic awareness and CRR than those who continue with the therapy allocated at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01DK135126 | NIH | None | httpsreporternihgovquickSearch1U01DK135126 |